A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B
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.
| Condition(s) | Chronic Hepatitis B Infection |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 ef |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Ausper Biopharma Co., Ltd. |
| Locations | Ch’ang-ch’un, Jilin, China |
| Start date | 2026-04-13 |
| NCT ID | NCT07511218 |
| Official listing | https://clinicaltrials.gov/study/NCT07511218 |