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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
subcutaneous injection
subcutaneous injection
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGNumber of participants with AEs, SAEs and abnormal laboratory testings
AEs: Adverse Events. SAEs: Serious Adverse Events.
Time frame: Approximate 24 weeks
Cmax: maximum concentration
Time frame: Pre-dose, multiple time-points post dose until 48 hours
Tmax
Tmax: Time to Maximum Concentration
Time frame: Pre-dose, multiple time-points post dose until 48 hours
AUC0-t
AUC0-t: Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration
Time frame: Pre-dose, multiple time-points post dose until 48 hours
AUC0-inf
AUC0-inf: Area Under the Concentration-Time Curve from Time Zero to Infinity
Time frame: Pre-dose, multiple time-points post dose until 48 hours
t1/2
t1/2: Half-life
Time frame: Pre-dose, multiple time-points post dose until 48 hours
λz
λz: Terminal Elimination Rate Constant
Time frame: Pre-dose, multiple time-points post dose until 48 hours
Vd/F
Vd/F: Volume of Distribution over Bioavailability
Time frame: Pre-dose, multiple time-points post dose until 48 hours
CL/F
CL/F: Clearance over Bioavailability
Time frame: Pre-dose, multiple time-points post dose until 48 hours
Css (Steady-State Concentration)
Time frame: Pre-dose, multiple time-points post dose until 48 hours
DF (Degree of Fluctuation)
Time frame: Pre-dose, multiple time-points post dose until 48 hours
The number of participants with chronic hepatitis B (CHB) who achieved hepatitis B surface antigen (HBsAg) clearance
Time frame: Approximate 24 weeks
Maximum HBsAg Decline in CHB Participants Within 24 Weeks (log10)
Time frame: Approximate 24 weeks
The number of CHB Participants with HBsAg Seroconversion at each assessment time Point within 24 weeks
Time frame: Approximate 24 weeks
The number of CHB participants who achieved HBeAg seronegativity at each assessment time point within 24 weeks
Time frame: Approximate 24 weeks
The number of participants with immunogenicity (i.e., anti-drug antibodies [ADAs])
Time frame: Approximate 24 weeks
The change in QTcF relative to baseline and the change relative to placebo
Apply for healthy participants
Time frame: Approximate 24 weeks
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