NCT07511218 A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants
| NCT ID | NCT07511218 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ausper Biopharma Co., Ltd. |
| Condition | Chronic Hepatitis B Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 110 participants in total. It began in 2026-04-13 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07511218 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Hepatitis B Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07511218 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07511218 currently recruiting?
Yes, NCT07511218 is actively recruiting participants. Contact the research team at clinicaltrial@ausperbio.com for enrollment information.
Where is the NCT07511218 trial being conducted?
This trial is being conducted at Ch’ang-ch’un, China, Hangzhou, China.
Who is sponsoring the NCT07511218 clinical trial?
NCT07511218 is sponsored by Ausper Biopharma Co., Ltd.. The trial plans to enroll 110 participants.