A Phase 2b, Placebo-Controlled, Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy Adults to Assess Protection Against Colonization Following Challenge With Virulent Wild-Type Bordetella Pertussis

This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.

Start Date20 Jun 2022

Sponsor / Collaborator

ILiAD Biotechnologies LLC

NCT05136599

/ CompletedPhase 1IIT

Open-label, Phase 1, Dose-escalation Clinical Trial to Establish a Controlled Human Infection Model by Determining the Optimal and Safe Bordetella Pertussis Dose That Induces Mild Symptomatic Infection and Colonization in Healthy Adults

This study aims to establish a Controlled Human Infection Model of Bordetella pertussis by determining a reproducible and safe infectious bacterial dose (challenge inoculum) that achieves colonization and mild symptomatic infection in healthy adults.

Start Date28 Jan 2022

Sponsor / Collaborator

Dalhousie University

[+3]

NCT05116241

/ CompletedPhase 2

Phase 2b Placebo-Controlled Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy School-Age Children to Assess Immunological Response and Safety of a Single Dose BPZE1 With/Without Coadministration of Tdap (Boostrix™)

This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. This is a multi-center, randomized, placebo- and active-comparator-controlled study in healthy, school-age children with a 6-month safety follow-up after the first vaccination.

Start Date11 Nov 2021

Sponsor / Collaborator

ILiAD Biotechnologies LLC

100 Clinical Results associated with Pertussis vaccine(INSERM)

100 Translational Medicine associated with Pertussis vaccine(INSERM)

100 Patents (Medical) associated with Pertussis vaccine(INSERM)

Literatures (Medical) associated with Pertussis vaccine(INSERM)

02 Jan 2026·Expert Opinion on Drug Delivery

The potential public health benefit of live-attenuated pertussis vaccines

Review

Author: Rubin, Keith ; Locht, Camille

INTRODUCTION:

Despite high vaccination coverage, pertussis remains endemic, and epidemic cycles continue to occur every 3-5 years, illustrating the shortcomings of current vaccination strategies. Unlike current vaccines, especially acellular pertussis vaccines, which prevent disease for short duration but do not prevent nasal colonization by the etiological agent Bordetella pertussis, natural infection can induce durable immunity against disease and infection. Accordingly, live-attenuated nasal pertussis vaccine candidates have been developed to mimic the immunogenicity of natural infection without causing disease.

AREAS COVERED:

We summarize the current status of live-attenuated nasal pertussis vaccines based on a literature search with keywords 'pertussis vaccine,' 'live,' and 'attenuated.' These candidates were designed based on different strategies, including dependence on critical metabolites for bacterial growth, genetic attenuation of virulence, and modification of immunomodulatory properties of Bordetella.

EXPERT OPINION:

Only vaccines based on genetic attenuation of virulence have reached clinical development thus far. The most advanced candidate is BPZE1, which has successfully completed six clinical studies, demonstrating safety, systemic and mucosal immunogenicity, and the ability to prevent or substantially reduce B. pertussis infection. If BPZE1 is eventually adopted for global use, it will likely be a major breakthrough in the ultimate control of pertussis, which has plagued humanity for centuries.

01 Dec 2025·Lancet Microbe

Efficacy, immunogenicity, and safety of the live attenuated nasal pertussis vaccine, BPZE1, in the UK: a randomised, placebo-controlled, phase 2b trial using a controlled human infection model with virulent Bordetella pertussis

Article

Author: Raud, Lucy ; Samal, Vivek ; Gbesemete, Diane ; Goldstein, Peter ; Laver, Jay R ; Hill, Alison R ; Faust, Saul N ; Locht, Camille ; Coutinho, Tyween ; Weissfeld, Lisa ; Dale, Adam P ; Ferreira, Daniela M ; Ramasamy, Maheshi N ; Rubin, Keith ; Noviello, Stephanie ; Guy, Jonathan ; Reed, Thomas A N ; Read, Robert C ; Babbage, Gavin ; Lang, Wei ; Ibrahim, Muktar ; Solovay, Ken

BACKGROUND:

Pertussis is a severe respiratory disease caused by Bordetella pertussis. Although vaccines prevent disease for a limited duration, they do not prevent infection and transmission. We aimed to assess the safety and efficacy of BPZE1 at preventing or substantially reducing colonisation by virulent B pertussis using a robust controlled human infection model.

METHODS:

This randomised, placebo-controlled, phase 2b trial was conducted at University Hospital Southampton and University of Oxford in the UK. Eligible participants were healthy adults aged 18-50 years, who complied with the protocol, refrained from smoking and nasal sprays, and were fully vaccinated against SARS-CoV-2. Exclusion criteria were pertussis vaccination or illness (<5 years), baseline anti-pertussis toxin serum IgG (>20 International Units [IU]/mL) or anti-pertactin serum IgG (>30 IU/mL) concentrations, and a positive SARS-CoV-2 test. Participants were randomly assigned (1:1), using permuted blocks with a block size of four, to receive an intranasal dose of 10⁹ colony-forming units (CFU) of BPZE1 or placebo (lyophilised buffer) and were challenged 60-120 days later with 10⁵ CFU virulent B pertussis. Masked staff administered the study vaccine. Nasal mucosal secretion and blood samples were collected. The primary outcome was negative B pertussis cultures of nasal washes at days 9, 11, and 14 after virulent challenge in the modified intention-to-treat (mITT; defined as all participants randomly assigned to treatment who were vaccinated, challenged, and had at least one culture result at day 9, 11, or 14 post-challenge) and per protocol adequate inoculum populations (defined as all participants in the mITT population who received a challenge inoculum equal to or higher than the target (≥0·5 × 10⁵ CFU; sensitivity analysis). This trial is registered with ClinicalTrials.gov, NCT05461131.

FINDINGS:

Between June 23, 2022, and Oct 26, 2023, 141 participants were assessed for eligibility, of whom 88 were ineligible and 53 were randomly assigned (26 to the BPZE1 group and 27 to the placebo group). 26 (49%) participants were male and 27 (51%) were female, with a mean age of 30·42 years (SD 8·49). Participants self-identified as White (42 [79%]), Black (six [11%]), or Asian (five [9%]). Five (9%) participants did not receive virulent challenge and two (4%) were lost to follow-up before virulent challenge. 46 (87%) participants received virulent challenge at 60-120 days (24 in the BPZE1 group vs 22 in the placebo group). One in the BPZE1 group withdrew consent and one in the placebo group was not evaluable due to COVID-19. 44 (83%) completed the challenge trial unit stay (23 [88%] vs 21 [78%]). 24 (92%) participants in the BPZE1 group and 21 (78%) in the placebo group were included in the mITT population. In the mITT population, the number of participants with no detectable colonisation on days 9, 11, and 14 post-challenge was higher in the BPZE1 group (14 [58%; 95% CI 39-76] of 24 vs seven [33%; 17-55] of 21 in the placebo group; p=0·091). Four (17%) in the BPZE1 group and five (24%) in the placebo group received a lower challenge dose than the target. In the per protocol adequate inoculum population, 12 (60%; 39-78) of 20 in the BPZE1 group and four (25%; 10-50) of 16 in the placebo group had no detectable colonisation by B pertussis B1917 on days 9, 11, and 14 post-challenge (p=0·033). Most participants reported at least one solicited adverse event during the 7 days after vaccination (22 [85%] of 26 in the BPZE1 group vs 22 [81%] of 27 in the placebo group), which were mostly mild (grade 1) in severity. Unsolicited adverse events were reported in similar frequency in the BPZE1 and placebo groups during the 28 days after vaccination (seven [27%] of 26 vs nine [33%] of 27). No serious adverse events or discontinuations due to adverse events were reported during the trial.

INTERPRETATION:

Intranasal BPZE1 vaccination prevented or substantially reduced infection after challenge with virulent B pertussis and is an attractive vaccine candidate. Given the favourable safety profile, large phase 3 trials are warranted to confirm these initial findings.

FUNDING:

ILiAD Biotechnologies.

01 Jul 2025·iScience

Protection of infant mice against pertussis, tuberculosis and influenza by co-administration of nasal pertussis vaccine candidate BPZE1 and BCG

Article

Author: Rouanet, Carine ; Cauchi, Stephane ; Mielcarek, Nathalie ; Debrie, Anne-Sophie

Protecting neonates at risk of serious pertussis disease or death represents a global emergency. BPZE1 is the most advanced, next-generation pertussis vaccine undergoing clinical evaluation in children and adults. We investigated the feasibility of co-administering BPZE1 and Bacillus Calmette-Guerin (BCG), the most widely used tuberculosis vaccine worldwide. We showed that BPZE1 can be co-administered with BCG without altering its immunogenicity and protective efficacy against B. pertussis in infant mice. Conversely, BCG immunogenicity and protective efficacy against M. tuberculosis are not affected by BPZE1. Both vaccines induce off-target protection against heterologous infections. In this study, we showed that BPZE1 and BCG alone or in combination induced high levels of protection against influenza challenge in infant mice. In contrast to BCG, the off-target properties of BPZE1 were independent of the age of vaccination. Vaccination with BPZE1 might be considered at the same time as BCG, facilitating its effective implementation in the childhood immunization schedule.

News (Medical) associated with Pertussis vaccine(INSERM)

10 Feb 2026

·www.fiercebiotech.com

ILiAD Biotechnologies snags $115M series B for whooping cough vaccine

ILiAD Biotechnologies leadership hopes the company\'s oral whooping cough vaccine will increase access to protect against a disease that\'s making a resurgence throughout the U.S.\n ILiAD Biotechnologies has closed an oversubscribed $115 million series B fundraise to support the company’s next-generation whooping cough vaccine candidate.Led by RA Capital Management, and with participation from new partners Janus Henderson Investors and BNP Paribas Asset Management, the funds will help ILiAD advance live attenuated intranasal pertussis vaccine BPZE1. The candidate targets adults and adolescents and is designed to be more durable than existing vaccines in the prevention of whooping cough—also known as Bordetella pertussis—infection, disease and transmission.Joining RA and the new investors are existing backers including a multinational pharmaceutical company and AI Life Sciences, according to a Feb. 10 release. “BPZE1 represents a compelling opportunity to address the ongoing burden of pertussis,” RA Capital Management’s head of infectious disease Mario Barro, Ph.D., said via release. Six clinical studies have demonstrated the drug\'s ability to advance pertussis prevention, and the oral treatment makes it more accessible, according to Barro. After being developed at the Institut Pasteur de Lille in France, clinical data have shown BPZE1 to block B. pertussis from spreading to adult and adolescent nasal passages and indirectly protect children and infants by preventing transmission to others. The Florida-based biotech says future development of the drug will target children and infants directly. In 2024, a phase 2b trial called Super (Stand Up to Pertussis) met its primary goal when administered to 366 healthy school-age children. The trial aimed to measure the vaccine’s ability to be co-administered as part of the DTaP childhood vaccine, and the immunological response and safety of a single dose of the nasal vaccine met the trial goals.“This immunity and potential ability to prevent transmission may one day protect not only school-age children around the world, but also their vulnerable contacts, particularly infants,” ILiAD CEO Keith Rubin, M.D., said in a statement at the time.Pertussis can be a life-threatening disease caused by highly contagious respiratory bacteria, causing about 200,000 pediatric deaths each year. Whooping cough is part of the recommended DTaP childhood vaccine, but decreased vaccination rates in the U.S. have cause pertussis to surge in recent years, with 6,600 domestic cases in 2025 representing a 25-fold increase in cases from 2023.The surge of cases in the U.S. and Europe has put whooping cough back in the news and the development pipelines of Big Pharma, and, in December, regulators in the U.S. and Europe approved Roche’s first point-of-care test for whooping cough. Designed for use in clinics and emergency rooms, the test can provide results in 15 minutes through Roche’s PCR testing system. Florida-based ILiAD, which was named a Fierce 15 winner in 2024, launched when it licensed BPZE1 from Pasteur in 2012. In 2022, ILiAD closed a $42.8 million funding round, which brought the total to $100 million raised to advance the asset. Along the way, the candidate has undergone four human clinical studies and received a fast-track designation from the FDA.The $115 million series B raise brings ILiAD\'s total money raised to $215 million. Ruben told Fierce Biotech in 2024 that ILiAD\'s innovation is increasingly necessary and relatively cheap to make and distribute. “There’s more than 7 billion people on Earth, and not a single one is properly vaccinated against Bordetella pertussis,\" he said at the time.

VaccinePhase 2Fast TrackDrug ApprovalClinical Result

10 Feb 2026

·firstwordpharma.com

ILiAD secures $115M to push intranasal pertussis vaccine to Phase III

As developers contend with a more complex vaccine policy landscape in the US, investors still appear to be ready to place sizable bets on candidates targeting diseases that remain difficult to control.On Tuesday, ILiAD Biotechnologies said it raised $115 million in an oversubscribed series B round to help fund Phase III testing of BPZE1, its investigational intranasal pertussis vaccine, with a pivotal human challenge study expected to begin this year. Initial results are due in 2027.Current prevention strategies rely on acellular pertussis vaccines such as DTaP, administered in a five-dose childhood series, and Tdap booster shots for adolescents and adults. While these are credited with protecting against severe disease, that protection can wane over time and are ineffective at preventing infection and transmission, factors that could contribute to outbreaks.Ongoing burdenDeveloped at France's Institut Pasteur de Lille, BPZE1 uses a live attenuated form of Bordetella pertussis delivered through a nasal spray. The vaccine contains genetic modifications that inactivate or reduce three B. pertussis toxins – mutated pertussis toxin, deleted dermonecrotic toxin and tracheal cytotoxin. In 2023, ILiAD unveiled Phase IIb results that it said had, for the first time, demonstrated a pertussis vaccine preventing nasopharyngeal B. pertussis colonisation in a human challenge model."BPZE1 represents a compelling opportunity to address the ongoing burden of pertussis," said Mario Barro, head of infectious diseases of RA Capital Management, which led the fundraise."Across six clinical studies, including a human challenge study published in The Lancet Microbe, BPZE1 has demonstrated the potential to meaningfully advance Bordetella pertussis prevention," he said. "Its needle-free administration facilitates broad access, and by inducing robust mucosal immunity, BPZE1 may provide a more natural and durable immune response capable of preventing both disease and transmission."The financing comes amid broader shifts in US vaccine policy and rhetoric, including the Centers for Disease Control and Prevention's new childhood immunisation schedule, which significantly scaled back the number of universally recommended vaccines, but retained pertussis vaccination.Aside from RA Capital, the series B also drew participation from new investors Janus Henderson Investors and BNP Paribas Asset Management, as well as existing investors including an unnamed multi-national pharmaceutical company and AI Life Sciences.

Phase 2VaccineClinical ResultPhase 3

10 Feb 2026

·www.biospace.com

ILiAD Biotechnologies Announces $115M Oversubscribed Series B Financing to Advance BPZE1 Pertussis Vaccine

Financing round led by RA Capital Management Proceeds to support Phase 3 development of BPZE1 with pivotal study to begin in 2026 WESTON, Fla.--(BUSINESS WIRE)--ILiAD Biotechnologies, Inc. (ILiAD), an advanced clinical stage biotech company focused on the prevention and treatment of disease caused by Bordetella pertussis , today announced the successful closing of an oversubscribed $115 million Series B financing. The financing was led by RA Capital Management with participation from new investors Janus Henderson Investors and BNP Paribas Asset Management Alts, as well as existing investors including a multi-national pharmaceutical company and AI Life Sciences. As part of the financing, Mario Barro, Ph.D., Head of Infectious Diseases at RA Capital Management has joined ILiAD’s Board of Directors. Proceeds from the Series B financing will support the advancement of ILiAD’s next generation pertussis vaccine candidate, BPZE1. Inducing both systemic and mucosal immunity, BPZE1 is a live attenuated intranasal pertussis vaccine designed to provide durable and comprehensive immunity for the prevention of B. pertussis infection, disease (whooping cough), and transmission. The Company expects to begin a pivotal human challenge trial of BPZE1 in 2026, with initial data expected in 2027. “BPZE1 represents a compelling opportunity to address the ongoing burden of pertussis,” said Mario Barro, Ph.D., of RA Capital Management. “Across six clinical studies, including a human challenge study published in The Lancet Microbe, BPZE1 has demonstrated the potential to meaningfully advance Bordetella pertussis prevention. Its needle-free administration facilitates broad access, and by inducing robust mucosal immunity, BPZE1 may provide a more natural and durable immune response capable of preventing both disease and transmission.” Keith Rubin, MD, Founder and CEO of ILiAD commented, “Today’s financing reflects the urgent need for better pertussis vaccines, the scientific rigor and operational discipline of our team, and the extraordinary potential BPZE1 holds to improve global public health. We are grateful to RA Capital for their diligent efforts to lead the round, to Janus and BNPP AM Alts for their active partnership during the financing process, and to existing investors and all those who came before in support of our mission to eradicate pertussis disease once and for all.” About Pertussis Pertussis (whooping cough) is a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis . According to U.S. Centers for Disease Control and Prevention, each year pertussis affects approximately 24 million people globally, accounting for nearly 160,000 deaths in children younger than 5 years. Although estimated global vaccination coverage is 84%, current vaccines have failed to control epidemics. About BPZE1 BPZE1 is a next-generation live-attenuated intranasal pertussis vaccine designed to induce comprehensive and durable protection against B. pertussis infection (colonization) and disease (whooping cough). BPZE1 is being developed to block B. pertussis from colonizing adult and adolescent nasal passages, to protect adults and adolescents from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and adolescents and to indirectly protect vulnerable infants, future development aims to immunize neonates directly. BPZE1 was developed at the Institut Pasteur de Lille (France) in the lab of Camille Locht and Nathalie Mielcarek. About ILiAD Biotechnologies ILiAD Biotechnologies ( ) is a privately held, advanced clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis . The company is developing and exploring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials. “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. In addition to historical facts or statements of current, this press release may contain forward-looking statements. Forward-looking statements provide ILiAD’s current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products, interpretation of clinical results, prospects for regulatory approval, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, rapid technological change, risks associated with acquisitions and investments, risks associated directly with BPZE technologies including but not limited to uncertainties of product development, and uncertainties of clinical development, dependence on third parties, competition, protection of patents and proprietary technology, potential for infringement and other statements regarding matters that are not historical fact. Some of these forward looking statements may be identified by use of words in the statements such as “estimate,” “intend,” or other words and terms of similar meaning. Statements in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore actual outcomes and results may differ materially from what is expressed in such forward-looking statements. ILiAD cautions investors not to place reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this release and ILiAD undertakes no obligations to update or review these statements, except as may be required by law. Contacts Bill Steinkrauss Chief Financial Officer ILiAD Biotechnologies, Inc. info@iliadbiotech.com 800.603.3525

VaccinePhase 2

100 Deals associated with Pertussis vaccine(INSERM)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Whooping Cough	Phase 2	United States	National Institute of Allergy & Infectious Diseases	23 Oct 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05461131 (CHAMPION-1, Pubmed \| Lancet Microbe) Manual	Phase 2	Whooping Cough	53	BPZE1 (intranasal 10⁹ CFU)	czvrpevovf(ensfohqnxq) = fkzsvghjmp dckifrzxgs (vlwdojmsem, 39 - 76) View more	Positive	01 Dec 2025
				Placebo	czvrpevovf(ensfohqnxq) = zwpfodknum dckifrzxgs (vlwdojmsem, 17 - 55) View more
NCT05116241 (SUPER, CTgov)	Phase 2	Whooping Cough	368	Placebo+Boostrix	sdgegmcujx(hncennnlch) = wrikhlwkyn eertnjyvct (fwwlaafdyz, cattkszmyn - wrdabmbgcx) View more	-	06 Nov 2025
NCT05461131 (CHAMPION-1, CTgov)	Phase 2	Whooping Cough	53	Bordetella Pertussis Challenge Strain+Azithromycin+BPZE1 (BPZE1)	dqsjouujii = wohyjwtalz zlilibmdvl (vwycmbnumw, zdsognfppx - hxqctqvimb) View more	-	12 Mar 2025
				Bordetella Pertussis Challenge Strain+Azithromycin (Placebo)	dqsjouujii = ygtjtbfozb zlilibmdvl (vwycmbnumw, xolokyooli - ydttkzugpk) View more
NCT05116241 (SUPER, Biospace) Manual	Phase 2	Whooping Cough	366	BPZE1	acvxgtugks(yvweelqikn) = Minimal reactogenicity was observed across all groups in this pediatric study, consistent with the favorable safety profile previously established in 5 adult clinical trials. hwfrwbbkdc (jxznwgzego )	Positive	28 May 2024
				BPZE1+Tdap
NCT03942406 (CTgov)	Phase 2	Whooping Cough	300	BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device (BPZE1 Intranasal Prime, BPZE1 Boost)	izchsleenn = pwwmqvqbmw mybsqgrwyf (kyaatvqdwd, yqdncwlpcs - xzxgoehdzd) View more	-	27 Jun 2023
				BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device (BPZE1 Intranasal Prime, Placebo Boost)	izchsleenn = gnxpschoye mybsqgrwyf (kyaatvqdwd, jnygirjopi - xuluhcypdp) View more
NCT03541499 (CTgov)	Phase 2	Whooping Cough	50	BPZE1 (BPZE1 10^7 CFU by VaxINator)	miamkuixnh = rgpppwjege gyfcktvkat (auwfndyqvo, hdtfmqgxtj - ztanflxxxp) View more	-	03 Feb 2022
				BPZE1 (BPZE1 10^9 CFU by VaxINator)	miamkuixnh = xmghwtukdr gyfcktvkat (auwfndyqvo, whxtjxmhtl - pizpdqbfnl) View more
NCT02453048 (Pubmed \| Lancet Infect Dis) Manual	Phase 1	-	48	BPZE1	ljlziasuud(zdbxbzaydb) = cporhhzorm uqiqnvarxf (hwfaicgubq ) View more	Positive	01 Nov 2020
				Placebo	jxbhbtgmjk(outzfpahsa) = thaigzoljn lvhhmayhro (ooguvcttlr )

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