Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AHB-171 Injection in Healthy Participants and Chronic Hepatitis B Participants
Led by Ausper Biopharma Co., Ltd. · Updated on 2026-06-01
110
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial evaluates the safety, tolerability, immune response, and pharmacokinetics of AHB-171 Injection in two groups: healthy adults and adults with chronic hepatitis B (CHB). It also assesses the preliminary effectiveness of AHB-171 in participants with CHB. The study is a Phase I trial sponsored by Ausper Biopharma Co., Ltd., aiming to gather important data on this investigational drug. Participants receive AHB-171 Injection or a placebo through subcutaneous injection. The study has two parts: Part A involves healthy participants receiving single ascending doses and monitoring up to 16 weeks, while Part B includes CHB participants receiving multiple ascending doses alongside background nucleos(t)ide analogue treatment, with follow-up up to 48 weeks. Both parts involve randomization and are conducted under quadruple masking. During the study, participants undergo various assessments including laboratory tests, electrocardiograms, physical exams, and vital sign monitoring. Researchers will measure drug levels in the blood and urine, immune responses, and liver-related markers such as hepatitis B surface antigen levels and liver enzyme ALT. Safety is closely monitored through reporting of adverse events and clinical evaluations. The study duration varies up to 48 weeks depending on the group and includes detailed pharmacokinetic and pharmacodynamic analyses.
CONDITIONS
Brief Title
A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged 18 to 55 years
- Body mass index between 18.0 and 28.0 kg/m2 for healthy participants
- Normal or clinically insignificant lab safety tests, ECG, abdominal and thyroid ultrasounds, chest X-ray for healthy participants
- Female healthy participants of childbearing potential must have a negative pregnancy test and agree to use contraception and avoid egg donation until 6 months after last dose
- Male healthy participants must agree to use effective contraception and avoid sperm donation until 6 months after last dose
- Liver and kidney function tests must meet requirements at screening for healthy participants
- CHB participants aged 18 to 65 years
- Body mass index between 18.0 and 32.0 kg/m2 for CHB participants
- CHB participants must take effective contraception as required
- CHB participants must have HBsAg > 100 IU/mL and ≤ 3000 IU/mL, and HBV DNA < 100 IU/mL at screening
- CHB participants must have received stable nucleos(t)ide analogue treatment for at least 6 months and stable on same treatment for at least 3 months before screening
You will not qualify if you...
- Currently participating in another study or within 3 months of last investigational drug dose for both healthy and CHB participants
- Presence of cardiovascular, neurological, renal, immunological, metabolic diseases or malignant tumors in healthy participants
- Major surgery or severe trauma within past 6 months in healthy participants
- Acute infection within 14 days or vaccination within 28 days prior to screening in healthy participants
- Allergy to any investigational drug component
- Heavy smoking (>5 cigarettes/day), history of drug/alcohol abuse, or caffeine/alcohol consumption within 48 hours before dosing
- Blood donation/loss ≥400 mL or transfusion within 12 weeks, or planned donation during study
- Abdominal skin issues affecting drug injection or observation
- Positive for HBV, HCV, HIV, or syphilis in healthy participants
- Clinically significant ECG abnormalities or risk factors for torsades de pointes
- Presence of ascites, gastrointestinal bleeding, hepatic encephalopathy, or varices in CHB participants
- History or suspicion of hepatocellular carcinoma or AFP > 50 ng/mL in CHB participants
- Diagnosed or suspected cirrhosis within 12 months in CHB participants
- History of transplantation, autoimmune diseases, or severe systemic diseases besides chronic HBV in CHB participants
- Use of antisense oligonucleotide, siRNA therapies, or interferon within 12 months in CHB participants
- Planned surgery during study or acute infection within 14 days in CHB participants
- Key laboratory results unsuitable for clinical trial
- Positive for HIV, HCV, or active syphilis; uncured hepatitis A, D, or E in CHB participants
- Any condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 16 weeks for healthy participants; up to 48 weeks for CHB participants
Participants receive AHB-171 Injection or placebo via subcutaneous injection, with some CHB participants also continuing stable oral nucleos(t)ide analogue treatment.
Multiple visits during treatment period depending on cohort assignment
Duration - Up to 48 weeks for CHB participants; up to 16 weeks for healthy participants
Participants are monitored for safety, pharmacokinetics, and efficacy outcomes after treatment ends.
Periodic visits for up to 48 weeks
Trial Site Locations
Total: 1 location
1
AusperBio Investigational Site
Ch’ang-ch’un, Jilin, China
Actively Recruiting
Research Team
B
Bella Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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