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SA1211 Injection Phase 1 Study
Sponsor: Suzhou Siran Biotechnology Co.,Ltd.
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.
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA1211 Injection in Healthy Participants and Participants With Chronic Hepatitis B
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-11-25
Completion Date
2027-03-30
Last Updated
2025-12-10
Healthy Volunteers
Yes
Conditions
Interventions
SA1211 injection
subcutaneous injection
SA1211 injection placebo
subcutaneous injection
Locations (1)
The First Hospital of Jilin University
Changchun, Jilin, China