Clinical Trial

SA1211 Injection Phase 1 Study

Recruiting Phase 1
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Summary
The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of SA1211 Injection in healthy volunteers (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in participants with chronic hepatitis B (CHB). The main questions it aims to answer are: What are the safety, tolerability, immunogenicity and PK characteristics of a single subcutaneous injection of SA1211 Injection in healthy volunteers (Part A)? What are the safety, tolerability, immunogenicity and PK characteristics of multiple subcutaneous injections of SA1211 Injection in participants with CHB (Part B)? What is the preliminary efficacy of SA1211 Injection in participants with CHB (Part B)? Participants will: * Part A (healthy volunteers): Receive a single subcutaneous injection of SA1211 Injection or placebo and complete relevant safety, tolerability and PK monitoring as required. * Part B (participants with CHB): Receive multiple subcutaneous injections of SA1211 Injection or placebo and complete relevant safety, tolerability, PK monitoring and preliminary efficacy assessment as required.
Trial Details
NCT Number NCT07275918
Lead Sponsor Suzhou Siran Biotechnology Co.,Ltd.
Collaborators: Beijing Siran Biotechnology Co.,Ltd.
Conditions Chronic Hepatitis B
Enrollment 80 participants
Start Date 2025-11-25
Primary Completion 2027-03-30 (estimated)
Study Completion 2027-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-10