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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
AusperBio Investigational Site
RECRUITING
Ch’ang-ch’un
Contact Information
Primary
Bella Lu
clinicaltrial@ausperbio.com
0571-86959519
Time Frame
Start Date: 2026-04-13
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 110
Treatments
Experimental: AHB-171 and placebo in CHB (Part B: MAD)
Drug: AHB-171 Injection Drug: Placebo Drug: Nucleos(t)ide Analogue (NA) Background treatment
Experimental: AHB-171 and placebo in HP(Part A: SAD)
Drug: AHB-171Injection Drug: Placebo
Related Therapeutic Areas
Sponsors
Leads: Ausper Biopharma Co., Ltd.

This content was sourced from clinicaltrials.gov

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