Delving into the Latest Updates on ADC-189 with Synapse

主要目的：评价ADC189片/颗粒治疗儿童流感受试者的安全性。次要目的：（1）评价ADC189片/颗粒在儿童流感受试者中活性代谢产物ADC189-I07的药代动力学（PK）特征；并评估ADC189-I07暴露-效应关系。（2）评价ADC189片/颗粒治疗儿童流感受试者的有效性。（3）评价ADC189片/颗粒在儿童流感受试者中的耐药性。

[Translation]

Primary objective: To evaluate the safety of ADC189 tablets/granules in treating pediatric influenza subjects. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of the active metabolite ADC189-I07 of ADC189 tablets/granules in pediatric influenza subjects; and to assess the exposure-effect relationship of ADC189-I07. (2) To evaluate the efficacy of ADC189 tablets/granules in treating pediatric influenza subjects. (3) To evaluate the drug resistance of ADC189 tablets/granules in pediatric influenza subjects.

Start Date19 Aug 2024

Sponsor / Collaborator

Jiaxing'an Dikang Biotechnology Co., Ltd.

CTR20242650

/ CompletedPhase 1

评价ADC189片与伊曲康唑胶囊在健康成年受试者中药物相互作用的单中心、开放、序贯给药的I期临床研究

[Translation] A single-center, open-label, sequential administration phase I clinical study to evaluate the drug-drug interaction between ADC189 tablets and itraconazole capsules in healthy adult subjects

主要研究目的:评价伊曲康唑胶囊对中国健康受试者单次口服ADC189后，体内ADC189及其主要代谢产物ADC189-I07药代动力学特征的影响。次要研究目的:评估联合服用伊曲康唑和ADC189片在中国健康受试者中的安全性。

[Translation]

The primary study objective is to evaluate the effect of itraconazole capsules on the pharmacokinetic characteristics of ADC189 and its major metabolite ADC189-I07 in healthy Chinese subjects after a single oral dose of ADC189. The secondary study objective is to evaluate the safety of combined use of itraconazole and ADC189 tablets in healthy Chinese subjects.

Start Date22 Jul 2024

Sponsor / Collaborator

Jiaxing'an Dikang Biotechnology Co., Ltd.

NCT06589635

/ CompletedPhase 1

A Single-center, Open-label and Sequential-dosing Clinical Trial Investigating the Drug Interaction Between ADC-189 Tablet and Itraconazole Capsule in Healthy Adult Subjects

This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ADC189 in healthy adults.
Participants in this study will complete screening assessments within 14 days before the first dose of ADC189. Participants will be admitted to the clinical pharmacology center (CPC) and complete 2 periods of treatments. On Day 1 and 26, each participant will receive a single oral dose of ADC189 (45mg), under fasting condition On Day 22, all participants will receive oral doses of itraconazole 200 mg (bid), after meal. From Day 23 to Day 25, and Day 26-D39, participants will receive itraconazole 200 mg(qd). Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26. Participants will receive a telephone follow-up on D47 (±3) days for a final visit.

Start Date16 Jul 2024

Sponsor / Collaborator

Jiaxing'an Dikang Biotechnology Co., Ltd.

100 Clinical Results associated with ADC-189

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100 Translational Medicine associated with ADC-189

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100 Patents (Medical) associated with ADC-189

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2

Literatures (Medical) associated with ADC-189

01 Apr 2025·Journal of Infection

Oral ADC189 for adults and adolescents with uncomplicated influenza

Article

Author: Wang, Sikui ; Sheng, Guoping ; Tian, Dongbo ; Wu, Hong ; Chen, Xiaolin ; Hu, Junyan ; Ye, Feng ; Qu, Lihong ; Lyu, Yingqi ; Li, Weiyang ; Zheng, Huanwei ; Zhu, Xiaoyun ; Li, Yongzhong ; Gao, Feng ; Feng, Yan ; Sun, Yilan ; Qu, Jieming ; Wu, Bin ; Zhao, Jingya ; Deng, Min ; Peng, Jie ; Wang, Hong ; Jiang, Xuehong ; Chen, Meifang ; Zhou, Min ; Chen, Lin ; Tan, Jie ; Xu, Xiaowei ; Peng, Chunxian ; Shao, Lei

OBJECTIVESADC189 is a novel anti-influenza virus inhibitor. In this study, we aimed to evaluate the safety and efficacy of ADC189 in outpatients with uncomplicated influenza infection.METHODSIn the phase 2 trial, we assigned patients in a 2:2:1 ratio to receive either single dose 15-mg or 45-mg of ADC189 or placebo. In the phase 3 part, participants were randomized in a 2:1 ratio to receive 45-mg of ADC189 or placebo. The primary endpoint was the time to alleviation of influenza symptoms in the intention-to-treat infected population.RESULTSIn the phase 2 trial that had 150 participants, the median time for virus RNA clearance was shorter in both ADC189 groups (15-mg group, 50·7 h; 45 mg-group, 45·8 h) compared to the placebo group (73·4 h; p=0·69 and 0·016, respectively). 617 participants were enrolled in the phase 3 trial. The median time to symptom alleviation was 50·0 h (95% CI, 44·6 to 59·3) with ADC189, as compared with 68·1 h (95% CI, 62·8 to 84·4) with placebo (p<0·0001). By 1 day after initiation, the decrease in viral load from baseline was greater in the ADC189 group than in the placebo group (2·316 and 1·049 log₁₀ virus copies per milliliter, respectively). Most adverse events were mild or moderate.CONCLUSIONSA single-dose ADC189 shorten the time to the resolution of symptoms among adults and adolescents with uncomplicated influenza, without evident safety concerns. (Funded by Jiaxing AnDiCon Biotech Co., Ltd, Zhejiang, China; ChiCTR number, 20230137, and ClinicalTrials. gov number, NCT06342921.).

Frontiers of Medicine

Inhibition of cap-dependent endonuclease in influenza virus with ADC189: a pre-clinical analysis and phase I trial

Article

Author: Chen, Jian ; Tang, Chunlei ; Zhu, Xiaoyun ; Xiao, Xin ; Wei, Jing ; Deng, Yaping ; Yang, Yang

ADC189 is a novel drug of cap-dependent endonuclease inhibitor. In our study, its antiviral efficacy was evaluated in vitro and in vivo, and compared with baloxavir marboxil and oseltamivir. A first-in-human phase I study in healthy volunteers included single ascending dose (SAD) and food effect (FE) parts. In the preclinical study, ADC189 showed potent antiviral activity against various types of influenza viruses, including H1N1, H3N2, influenza B virus, and highly pathogenic avian influenza, comparable to baloxavir marboxil. Additionally, ADC189 exhibited much better antiviral efficacy than oseltamivir in H1N1 infected mice. In the phase I study, ADC189 was rapidly metabolized to ADC189-I07, and its exposure increased proportionally with the dose. The terminal elimination half-life (T_1/2) ranged from 76.69 to 98.28 hours. Of note, food had no effect on the concentration, clearance, and exposure of ADC189. It was well tolerated, with few treatment-emergent adverse events (TEAEs) reported and no serious adverse events (SAEs). ADC189 demonstrated excellent antiviral efficacy both in vitro and in vivo. It was safe, well-tolerated, and had favorable pharmacokinetic characteristics in healthy volunteers, supporting its potential for single oral dosing in clinical practice.

100 Deals associated with ADC-189

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza A virus infection	NDA/BLA	China	Jiaxing'an Dikang Biotechnology Co., Ltd.	15 Mar 2025
Influenza A virus infection	NDA/BLA	China	STA Pharmaceutical Co. Ltd.	15 Mar 2025
Influenza B virus infection	NDA/BLA	China	STA Pharmaceutical Co. Ltd.	15 Mar 2025
Influenza B virus infection	NDA/BLA	China	Jiaxing'an Dikang Biotechnology Co., Ltd.	15 Mar 2025
Influenza, Human	Phase 3	China	Simcere Pharmaceutical Group Ltd.	10 Oct 2023