A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients

NCT06115993 | Active Not Recruiting Phase 1

• 1 other identifier: AB-10-8002
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137 in CHB participants after up to 24 weeks of treatment as a proof-of-concept.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (14)

• Number of healthy participants with TEAEs, SAEs

  Up to 30 days for SAD; up to 113 days for MAD

• Number of healthy participants with clinically significant changes in laboratory parameters

  Up to 30 days for SAD; up to 113 days for MAD

• Number of healthy participants with clinically significant changes in vital signs

  Up to 30 days for SAD; up to 113 days for MAD

• Number of healthy participants with clinically significant changes in ECG

  Up to 30 days for SAD; up to 113 days for MAD

• Number of healthy participants with ADA

  Up to 30 days for SAD; up to 113 days for MAD

• The pharmacokinetic profile of AHB-137 in healthy participants: the Cmax of AHB-137

  Up to 30 days for SAD; up to 113 days for MAD

• The pharmacokinetic profile of AHB-137 in healthy participants: Tmax of AHB-137

  Up to 30 days for SAD; up to 113 days for MAD

• The pharmacokinetic profile of AHB-137 in healthy participants: AUC of AHB-137

  Up to 30 days for SAD; up to 113 days for MAD

• The pharmacokinetic profile of AHB-137 in healthy participants: t1/2 of AHB-137

  Up to 30 days for SAD; up to 113 days for MAD

• Number of CHB participants with TEAEs, SAEs

  Up to 113 days for Ib

• Number of CHB participants with clinically significant changes in laboratory parameters

  Up to 113 days for Ib

• Number of CHB participants with clinically significant changes in vital signs

  Up to 113 days for Ib

• Number of CHB participants with clinically significant changes in ECG

  Up to 113 days for Ib

• Proportion of participants achieving HBsAg lower than LLOQ (0.05 IU/mL) and HBV DNA lower than LLOQ at the end of treatment with AHB-137, regardless of whether HBsAg seroconversion is observed

  At week 24 for IIa

Secondary Outcomes (12)

• The anti-HBV efficacy of AHB-137 in CHB participants: evaluate the serum levels of HBV DNA, HBsAg, HBV RNA, HBsAb, HBeAb

  Up to 113 days for Ib; Up to 72 weeks for IIa

• Evaluate the serum levels of sensitive HBsAg (LLOQ ≤0.005 IU/mL) and HBcrAg.

  Up to 72 weeks for IIa

• The pharmacokinetic profile of AHB-137 in CHB participants: the Cmax of AHB-137

  up to 113 days for Ib; Up to 48 weeks for IIa

• The pharmacokinetic profile of AHB-137 in CHB participants: Tmax of AHB-137

  up to 113 days for Ib; Up to 48 weeks for IIa

• The pharmacokinetic profile of AHB-137 in CHB participants: AUC of AHB-137

  up to 113 days for Ib; Up to 48 weeks for IIa

Study Arms (3)

Part Ia: dosing in healthy participants

EXPERIMENTAL

SAD of 75 mg, 150 mg, 300 mg and 450 mg AHB-137 and MAD of 150 mg and 300 mg AHB-137 by subcutaneous injections within a month in healthy participants.

Drug: AHB-137 injection; Drug: Placebo

Part Ib: dosing in CHB participants

EXPERIMENTAL

Dose escalation cohort: MAD of 150 mg and 300 mg AHB-137 by subcutaneous injections within a month in CHB participants who are under stable NAs therapy. Dose expansion cohort: Multiple doses of 300 mg AHB-137 by subcutaneous injections within a month in CHB participants who are under stable NAs therapy.

Drug: AHB-137 injection; Drug: Placebo

Part IIa: proof of concept

EXPERIMENTAL

Multiple doses of 225 mg or 300 mg AHB-137 by subcutaneous injections within 24 weeks in CHB participants who are under stable NAs therapy.

Drug: AHB-137 injection

Interventions

AHB-137 injection DRUG

AHB-137 injection will be administered subcutaneously.

Part IIa: proof of concept; Part Ia: dosing in healthy participants; Part Ib: dosing in CHB participants

Placebo DRUG

Placebo will be administered subcutaneously.

Part Ia: dosing in healthy participants; Part Ib: dosing in CHB participants

Eligibility Criteria

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

You may qualify if:

• The participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening;
• The participants are able to comply with all the protocol requirements;
• The participants (and partners) are willing to take effective contraceptive measures from the screening until at least 6 months after the last dosing;
• Male or female aged 18-55 when signing ICF;
• Body Mass Index (BMI) between 18 to 28 kg/m2 (inclusive) and body weight equal to or over 50 kg for male and 45 kg for female;
• Vital signs and physical examination are normal, or abnormal values are not clinically significant.
• The participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening;
• The participants are able to comply with all the protocol requirements;
• The participants (and partners) are willing to take effective contraceptive measures from the screening until at least 6 months after the last dosing;
• Male or female aged 18-65 when signing ICF;
• Body Mass Index (BMI) between 18 to 32 kg/m2 (inclusive) and body weight equal to or over 45 kg for male and 40 kg for female;
• participants who have documented chronic HBV infection equal to or above 6 months prior to screening.
• Stable treatment of HBeAg negative CHB participants;
• Currently receiving single-agent treatment with stable NAs (TDF, TAF, or ETV) for at least 6 months and no changes in the NAs treatment regimen are planned during the trial;
• Serum ALT≤2×ULN, HBV DNA \< 100 IU/mL. Dose increasing stage of Ib: 100 IU/mL \<HBsAg≤1000 IU/mL; Dose expansion stage of Ib: 1000 IU/ml \< HBsAg≤3000 IU/mL at screening; IIa phase: 100 IU/ml \< HBsAg≤ 3000 IU/mL at screening;

You may not qualify if:

• Any suspicat screening ion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
• Blood donation or blood loss not less than 400 mL within 12 weeks before screening;
• Drug administration that change the activity of liver enzymes within 28 days prior to screening;
• Receipt of another investigational drug or device within 3 months before first dosing (interventional treatment);
• Clinically significant electrocardiogram (ECG) abnormalities on screening ECG;
• TdP high-risk factors (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and QTc interval above 450 msec in participants (judged by investigator based on actual screening conditions);
• Pregnant (positive pregnancy test), recently ready to conceive, or lactating female;
• Clinically significant lab examination abnormalities, or other clinically significant diseases discovered within 12 months before screening, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, or cardiovascular and cerebrovascular diseases;
• Any acute disease or concomitant medication occurred during screening to the first dosing;
• Alcohol consumption, or positive alcohol test 24 hours before drug dosing;
• Positive test for urinalysis (including Morphine, Cannabis) in participants;
• Other factors resulting in participant becoming unsuitable for the study, determined by the investigator.
• Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
• Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
• Any oligonucleotide or siRNA treatments within 12 months before first dosing;

Sponsors & Collaborators

• Ausper Biopharma Co., Ltd.: lead

Study Sites (3)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, China

Location

The First Hospital of Jilin University

Jilin, China

Location

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

Study Officials

• Yanhua Ding

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Junqi Niu

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

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: October 11, 2023
• First Posted: November 3, 2023
• Study Start: August 3, 2023
• Primary Completion: December 3, 2024
• Study Completion: January 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)