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Clinical Trials in China / NCT07511218
Recruiting Phase 1

A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants

NCT07511218 · tracked via the Priya Life Science China tracker
Sponsor
Ausper Biopharma Co., Ltd.
Phase
Phase 1
Started
2026-04-13
Last updated
2026-07-21

Condition(s) studied

Chronic Hepatitis B Infection

Investigational drug(s) / intervention(s)

AHB-171 InjectionPlaceboNucleos(t)ide Analogue (NA)

AHB-171 Injection: AHB-171 Injection is adminstrated via subcutaneous injection

Placebo: Placebo is admistrated via subcutaneous injection

Nucleos(t)ide Analogue (NA): Oral administration

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy Participants: * Male or female participants, aged 18-55 years old (inclusive); * Body mass index between 18.0 and 28.0 kg/m\^2 (inclusive); * Laboratory safety tests during the screening period, 12-lead electrocardiogram (ECG), abdominal ultrasound, thyroid ultrasound, chest anteroposterior position, etc., are assessed by the investigatoras normal or abnormal without clinical significance; * Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening, and must agree to use effective contraceptive methods and refrain from donating eggs from screening until 6 months after the last dose of the study drug. * Male participants must agree to use highly effective contraceptive methods (to ensure effective contraception for their female partners of childbearing potential) and refrain from donating sperm from screening until 6 months after the last dose of the study drug. Liver and kidney function tests meet the requirements at the time of screening. * CHB Participants: * Male or female participants, aged 18-65 years old (inclusive); * Body mass index between 18.0 and 32.0 kg/m\^2 (inclusive); * Participants who take effective contraceptive measures as required; * HBsAg \> 100 IU/mL and ≤ 3000 IU/mL, and HBV DNA \< 100 IU/mL at screening. * Have received stable treatment with NA for at least 6 months and stable on the same NA for at least 3 months before screening. Exclusion Criteria: * Healthy Participants: * Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product. * Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within the past 6 months. * Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening. * Allergy to any investigational drug component. * Heavy Smoking (\> 5 cigarettes/day); history of drug/alcohol abuse; consumption of caffeine or alcohol within 48 hours before dosing. * Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study. * Abdominal skin issues that may affect drug injection/observation. * Positive for HBV, HCV, HIV, or syphilis. * Clinically significant ECG abnormality or TdP risk factors. * Any condition judged unsuitable by investigator. * CHB Participants: * Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product. * Presence of ascites, gastrointestinal bleeding, hepatic encephalopathy, or varices. * History or suspicion of hepatocellular carcinoma (HCC); AFP \> 50 ng/mL. * Diagnosed or Suspected cirrhosis within 12 months. * History of transplantation, autoimmune diseases, or severe systemic diseases (besides chronic HBV). * Use of ASO, siRNA (oligonucleotide therapies), or interferon within 12 months. * Major injury/surgery within 6 months, planned surgery during study, or acute infection within 14 days. * Allergy to any investigational drug component. * Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study. * Abdominal skin issues that may affect drug injection/observation. * Key laboratory result not suitable for clinical trial. * HIV, HCV, or active syphilis infection; uncured hepatitis A, D, or E. * Clinically significant ECG abnormality or TdP risk factors. * Any condition judged unsuitable by investigator.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
AusperBio Investigational Site Ch’ang-ch’un Jilin Recruiting
AusperBio Investigational Site Hangzhou Zhejiang Recruiting

More Ausper Biopharma Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07511218 on ClinicalTrials.gov ↗ ← All trials in China