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

NCT07511218 | Recruiting Phase 1

• 1 other identifier: AB-17-8002
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Hepatitis B Infection

Keywords

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (14)

• Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

• Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

• Change from baseline in laboratory tests

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

• Change from baseline in physical examinations

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

• Change from baseline in vital signs

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

• Change from baseline in electrocardiograms (ECGs)

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

• Part A:Plasma Cmax of AHB-171

  Up to Day 8

• Part A:Plasma Tmax of AHB-171

  Up to Day 8

• Part A Plasma AUC of AHB-171

  Up to Day 8

• Part A Plasma t1/2 of AHB-171

  Up to Day 8

• Proportion of participants with clinically significant abnormalities in laboratory tests

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

• Proportion of participants with clinically significant abnormalities in electrocardiograms (ECGs)

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

• Proportion of participants with physical examinations

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

• Proportion of participants with other vital signs

  PartA:Up to 16 weeks, PartB: Up to 48 weeks

Secondary Outcomes (18)

• Part A & Part B:Fraction excreted in urine in percentage for AHB-171

  Up to Day 3 in Part A; Up to Day 30 in Part B

• Part A & Part B:Amount excreted in urine for AHB-171

  Up to Day 3 in Part A; Up to Day 30 in Part B

• Part A & Part B:Renal clearance for AHB-171

  Up to Day 3 in Part A; Up to Day 30 in Part B

• Part A & Part B: Immunogenicity: The number of participants develop anti-drug antibodies (ADA) against AHB-171 and the ADA antibody titer

  Up to 16 weeks in Part A; Up to 48 weeks in Part B

• Part B:Plasma Cmax of AHB-171

  Up to Day 31

Study Arms (2)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

Drug: AHB-171Injection Drug: Placebo

Drug: AHB-171 Injection; Drug: Placebo

Interventions

AHB-171 Injection DRUG

AHB-171 Injection is adminstrated via subcutaneous injection

AHB-171 and placebo in CHB (Part B: MAD); AHB-171 and placebo in HP(Part A: SAD)

Placebo DRUG

Placebo is admistrated via subcutaneous injection

AHB-171 and placebo in CHB (Part B: MAD); AHB-171 and placebo in HP(Part A: SAD)

Nucleos(t)ide Analogue (NA) DRUG

Oral administration

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ausper Biopharma Co., Ltd.: lead

Study Sites (2)

AusperBio Investigational Site

Ch’ang-ch’un, Jilin, China

RECRUITING

AusperBio Investigational Site

Hangzhou, Zhejiang, 310052, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bella Lu

CONTACT

0571-86959519; clinicaltrial@ausperbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)