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

July 20, 2026 updated by: Ausper Biopharma Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jilin
      • Ch’ang-ch’un, Jilin, China
        • Recruiting
        • AusperBio Investigational Site
        • Principal Investigator:
          • Yanhua Ding
        • Principal Investigator:
          • Junqi Niu
        • Contact:
    • Zhejiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Part A:Plasma Cmax of AHB-171
Time Frame: Up to Day 8
Up to Day 8
Part A:Plasma Tmax of AHB-171
Time Frame: Up to Day 8
Up to Day 8
Part A Plasma AUC of AHB-171
Time Frame: Up to Day 8
Up to Day 8
Part A Plasma t1/2 of AHB-171
Time Frame: Up to Day 8
Up to Day 8
Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks
Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in laboratory tests
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in physical examinations
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in vital signs
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks
Change from baseline in electrocardiograms (ECGs)
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks
Proportion of participants with clinically significant abnormalities in laboratory tests
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks
Proportion of participants with clinically significant abnormalities in electrocardiograms (ECGs)
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks
Proportion of participants with physical examinations
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks
Proportion of participants with other vital signs
Time Frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks
PartA:Up to 16 weeks, PartB: Up to 48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Part A & Part B:Fraction excreted in urine in percentage for AHB-171
Time Frame: Up to Day 3 in Part A; Up to Day 30 in Part B
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
Time Frame: Up to Day 3 in Part A; Up to Day 30 in Part B
Up to Day 3 in Part A; Up to Day 30 in Part B
Part A & Part B:Renal clearance for AHB-171
Time Frame: Up to Day 3 in Part A; Up to Day 30 in Part B
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
Time Frame: Up to 16 weeks in Part A; Up to 48 weeks in Part B
Up to 16 weeks in Part A; Up to 48 weeks in Part B
Part B:Plasma Cmax of AHB-171
Time Frame: Up to Day 31
Up to Day 31
Part B:Plasma Tmax of AHB-171
Time Frame: Up to Day 31
Up to Day 31
Part B Plasma AUC of AHB-171
Time Frame: Up to Day 31
Up to Day 31
Part B Plasma t1/2 of AHB-171
Time Frame: Up to Day 31
Up to Day 31
Part B: Proportion of CHB who achieved hepatitis B surface antigen (HBsAg) clearance
Time Frame: Up to 48 weeks
Up to 48 weeks
Part B: HBsAg Decline in CHB Participants at each assessment time point
Time Frame: Up to 48 weeks
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.
Time Frame: Up to 48 weeks
Up to 48 weeks
Part B Proportion of participants achieve seroconversion to anti-HBs (HBsAb >10 IU/L) after HBsAg loss.
Time Frame: Up to 48 weeks
Up to 48 weeks
Part B Proportion of participants with HBV DNA < LLOQ (10 IU/mL)
Time Frame: Up to 48 weeks
Up to 48 weeks
Part B Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ at each assessment time point
Time Frame: Up to 48 weeks
Up to 48 weeks
Part B Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb , HBeAb , HBeAg
Time Frame: Up to 48 weeks
Up to 48 weeks
Part B The level of ALT.
Time Frame: Up to 48 weeks
Up to 48 weeks
PartB: Proportion of participants achieving ALT normalization and time to ALT normalization among those with baseline ALT > ULN.
Time Frame: Up to 48 weeks
Up to 48 weeks
Part B Correlation between pharmacokinetic and pharmacodynamic parameters of AHB-171
Time Frame: Up to 48 weeks
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ausper Biopharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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