AHB-171 injectable therapy in healthy adults and chronic hepatitis B patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study examines AHB-171 injections compared with placebo and existing nucleos(t)ide analogue therapy. Part A enrolls healthy adults aged 18-55, while Part B enrolls adults with chronic hepatitis B to assess safety, tolerability, immunogenicity, and pharmacokinetics, with preliminary signals of efficacy in CHB participants. The study uses a dose-ascending approach to characterize PK and immune response, and to identify any early clinical signals. Primary objectives focus on safety and tolerability; secondary objectives include immunogenicity and preliminary efficacy in CHB. The trial is conducted at two AusperBio investigational sites in China and is sponsored by Ausper Biopharma Co., Ltd.

Why it matters

Who can join: the full rules

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.

Where it's running

• AusperBio Investigational Site
  Ch’ang-ch’un, Jilin, China Recruiting
• AusperBio Investigational Site
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Bella Lu
• Email: clinicaltrial@ausperbio.com
• Phone: 0571-86959519

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.