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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAusper Biopharma Co., Ltd.

About this trial

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 criteria

Qualifiers

Male or female participants, aged 18-55 years old (inclusive);

Body mass index between 18.0 and 28.0 kg/m² (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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • AHB-171 Injection
  • Placebo
  • Nucleos(t)ide Analogue (NA)

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators