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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis B Infection
• Intervention / Treatment: Drug: AHB-171 Injection; Drug: Placebo; Drug: Nucleos(t)ide Analogue (NA)

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bella Lu; Phone Number: 0571-86959519; Email: clinicaltrial@ausperbio.com

Study Locations

• China
  • Jilin
    • Ch’ang-ch’un, Jilin, China
      • Recruiting
      • AusperBio Investigational Site
      • Principal Investigator: Yanhua Ding
      • Principal Investigator: Junqi Niu
      • Contact: Bella Lu; Phone Number: 0571-86959519; Email: clinicaltrial@ausperbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AHB-171 and placebo in HP(Part A: SAD); Drug: AHB-171Injection Drug: Placebo	Drug: AHB-171 Injection; AHB-171 Injection is adminstrated via subcutaneous injection; Drug: Placebo; Placebo is admistrated via subcutaneous injection
Experimental: AHB-171 and placebo in CHB (Part B: MAD); Drug: AHB-171 Injection Drug: Placebo Drug: Nucleos(t)ide Analogue (NA) Background treatment	Drug: AHB-171 Injection; AHB-171 Injection is adminstrated via subcutaneous injection; Drug: Placebo; Placebo is admistrated via subcutaneous injection; Drug: Nucleos(t)ide Analogue (NA); Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
Proportion of participants with clinically significant abnormalities in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs	PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs	PartA:Up to 16 weeks, PartB: Up to 48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Part B:Plasma Tmax of AHB-171	Up to Day 31
Part B Plasma AUC of AHB-171	Up to Day 31
Part B Plasma t1/2 of AHB-171	Up to Day 31
Part B: Proportion of CHB who achieved hepatitis B surface antigen (HBsAg) clearance	Up to 48 weeks
Part B: HBsAg Decline in CHB Participants at each assessment time point	Up to 48 weeks
Part B:Proportion of participants with HBsAg < 1 IU/mL, < 10 IU/mL, and < 100 IU/mL at each assessment time point.	Up to 48 weeks
Part B Proportion of participants achieve seroconversion to anti-HBs (HBsAb >10 IU/L) after HBsAg loss.	Up to 48 weeks
Part B Proportion of participants with HBV DNA < LLOQ (10 IU/mL)	Up to 48 weeks
Part B Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ at each assessment time point	Up to 48 weeks
Part B Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb , HBeAb , HBeAg	Up to 48 weeks
Part B The level of ALT.	Up to 48 weeks
PartB: Proportion of participants achieving ALT normalization and time to ALT normalization among those with baseline ALT > ULN.	Up to 48 weeks
Part B Correlation between pharmacokinetic and pharmacodynamic parameters of AHB-171	Up to 48 weeks

Collaborators and Investigators

• Sponsor: Ausper Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hepatitis B, Chronic
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: AB-17-8002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No