Delving into the Latest Updates on HRS-5635 with Synapse

Overview

Basic Info

Drug Type

siRNA

Synonyms

HRS 5635, HRS-5635, HRS5635

Target

HBV RNA

Action

inhibitors

Mechanism

HBV RNA inhibitors(HBV RNA inhibitors)

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis B, Chronic

Inactive Indication-

Originator Organization

Fujian Suncadia Pharmaceuticals Co Ltd.

Active Organization

Fujian Suncadia Pharmaceuticals Co Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (China)

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Structure/Sequence

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This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks) and the off-treatment follow-up (24 weeks), is up to approximately 88 weeks at maximum for each participant.

Start Date01 Jun 2026

Sponsor / Collaborator

Fujian Suncadia Pharmaceuticals Co Ltd.

NCT06425341

/ RecruitingPhase 2

A Multicenter, Randomized, Open, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B

A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.

Start Date06 Jun 2024

Sponsor / Collaborator

Fujian Suncadia Pharmaceuticals Co Ltd.

NCT05808374

/ Unknown statusPhase 1

Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.

Start Date30 Apr 2023

Sponsor / Collaborator

Fujian Suncadia Pharmaceuticals Co Ltd.

100 Clinical Results associated with HRS-5635

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100 Translational Medicine associated with HRS-5635

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100 Patents (Medical) associated with HRS-5635

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100 Deals associated with HRS-5635

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