The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of AHB-171 Injection in healthy participants (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in CHB participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
AHB-171 Injection is adminstrated via subcutaneous injection
Placebo is admistrated via subcutaneous injection
Oral administration
AusperBio Investigational Site
Ch’ang-ch’un, Jilin, China
RECRUITINGPart A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
Proportion of participants with clinically significant abnormalities in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs
Time frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs
Time frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
Part A:Plasma Cmax of AHB-171
Time frame: Up to Day 8
Part A:Plasma Tmax of AHB-171
Time frame: Up to Day 8
Part A Plasma AUC of AHB-171
Time frame: Up to Day 8
Part A Plasma t1/2 of AHB-171
Time frame: Up to Day 8
Part A & Part B:Fraction excreted in urine in percentage for AHB-171
Time frame: Up to Day 3 in Part A; Up to Day 30 in Part B
Part A & Part B:Amount excreted in urine for AHB-171
Time frame: Up to Day 3 in Part A; Up to Day 30 in Part B
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Part A & Part B:Renal clearance for AHB-171
Time frame: Up to Day 3 in Part A; Up to Day 30 in Part B
Part A & Part B: Immunogenicity: The number of participants develop anti-drug antibodies (ADA) against AHB-171 and the ADA antibody titer
Time frame: Up to 16 weeks in Part A; Up to 48 weeks in Part B
Part B:Plasma Cmax of AHB-171
Time frame: Up to Day 31
Part B:Plasma Tmax of AHB-171
Time frame: Up to Day 31
Part B Plasma AUC of AHB-171
Time frame: Up to Day 31
Part B Plasma t1/2 of AHB-171
Time frame: Up to Day 31
Part B: Proportion of CHB who achieved hepatitis B surface antigen (HBsAg) clearance
Time frame: Up to 48 weeks
Part B: HBsAg Decline in CHB Participants at each assessment time point
Time frame: Up to 48 weeks
Part B:Proportion of participants with HBsAg < 1 IU/mL, < 10 IU/mL, and < 100 IU/mL at each assessment time point.
Time frame: Up to 48 weeks
Part B Proportion of participants achieve seroconversion to anti-HBs (HBsAb >10 IU/L) after HBsAg loss.
Time frame: Up to 48 weeks
Part B Proportion of participants with HBV DNA < LLOQ (10 IU/mL)
Time frame: Up to 48 weeks
Part B Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ at each assessment time point
Time frame: Up to 48 weeks
Part B Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb , HBeAb , HBeAg
Time frame: Up to 48 weeks
Part B The level of ALT.
Time frame: Up to 48 weeks
PartB: Proportion of participants achieving ALT normalization and time to ALT normalization among those with baseline ALT > ULN.
Time frame: Up to 48 weeks
Part B Correlation between pharmacokinetic and pharmacodynamic parameters of AHB-171
Time frame: Up to 48 weeks