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

Ausper Biopharma

Status and phase: Enrolling; Phase 1

Conditions: Chronic Hepatitis B Infection

Treatments: Drug: Nucleos(t)ide Analogue (NA); Drug: AHB-171 Injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07511218

AB-17-8002

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

AHB-171 and placebo in CHB (Part B: MAD)

Experimental group

Description:

Drug: AHB-171 Injection Drug: Placebo Drug: Nucleos(t)ide Analogue (NA) Background treatment

Treatment:

Drug: Placebo

Drug: AHB-171 Injection

Drug: Nucleos(t)ide Analogue (NA)

AHB-171 and placebo in HP(Part A: SAD)

Experimental group

Description:

Drug: AHB-171Injection Drug: Placebo

Treatment:

Drug: Placebo

Drug: AHB-171 Injection