AHB-171 injection in healthy adults and people with chronic hepatitis B
Tests AHB-171 injection for safety in healthy adults and adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants
Key facts
- Where
- Ch’ang-ch’un and Hangzhou, ChinaSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07511218, who can take part
Where in China
- Ch’ang-ch’unCh’ang-ch’un, ChinaTaking people
- HangzhouHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ausper Biopharma Co., Ltd.
- Trial code
- NCT07511218
- Record updated
- 21 July 2026
- Original description
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.Read full original descriptionShow less
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AHB - 171 Injection in Healthy Participants (HP) and Chronic Hepatitis B(CHB) Participants
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.
Inclusion: 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: Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product; Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening; Allergy to any investigational drug component; Abdominal skin issues that may affect drug injection/observation; Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product; Use of ASO, siRNA (oligonucleotide therapies), or interferon within 12 months; Allergy to any investigational drug component; Abdominal skin issues that may affect drug injection/observation; Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within the past 6 months; Heavy Smoking (> 5 cigarettes/day); history of drug/alcohol abuse; consumption of caffeine or alcohol within 48 hours before dosing; Positive for HBV, HCV, HIV, or syphilis; Any condition judged unsuitable by investigator; Presence of ascites, gastrointestinal bleeding, hepatic encephalopathy, or varices; History of transplantation, autoimmune diseases, or severe systemic diseases (besides chronic HBV); Major injury/surgery within 6 months, planned surgery during study, or acute infection within 14 days; HIV, HCV, or active syphilis infection; uncured hepatitis A, D, or E; Any condition judged unsuitable by investigator; Key laboratory result not suitable for clinical trial; Healthy Participants:; Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study; Clinically significant ECG abnormality or TdP risk factors; CHB Participants:; History or suspicion of hepatocellular carcinoma (HCC); AFP > 50 ng/mL; Diagnosed or Suspected cirrhosis within 12 months; Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study; Clinically significant ECG abnormality or TdP risk factors.