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NCT07511218RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 21 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
110 (estimated)
First submitted
30 Mar 2026
Start date
13 Apr 2026
Primary completion date
30 Dec 2027
Lead sponsor
Ausper Biopharma Co., Ltd.
Diseases
Hepatitis B
NCT number
NCT07511218

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 110
  • From 13 Apr 2026 to the primary completion date, 30 Dec 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Lab values

  • Key laboratory result not suitable for clinical trial.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AusperBio Investigational Site
Coordinator of this site? Confirm its status
Ch’ang-ch’unChinaRecruiting
AusperBio Investigational Site
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.