A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function.

NCT07600788 | Not Yet Recruiting Phase 1

• 1 other identifier: AB-10-8010
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical study evaluating the pharmacokinetic characteristics and safety of AHB-137 injection in participants with mild to moderate liver dysfunction and those with normal liver function.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B; Chronic

Outcome Measures

Primary Outcomes (2)

• Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax)

  Up to day 29

• Key PK parameters of AHB-137 injection after single subcutaneous administration: area under the drug time curve from 0 to infinity (AUC)

  Up to day 29

Secondary Outcomes (6)

• PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last)

  Up to day 29

• PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24)

  Up to day 29

• PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168)

  Up to day 29

• PK parameter: D8 blood concentration (C168)

  Up to day 29

• PK parameter: peak time (Tmax)

  Up to day29

Study Arms (4)

Part1: Child-Pugh B group

EXPERIMENTAL

Drug: AHB-137 injection

Part2: Child-Pugh A group

EXPERIMENTAL

Drug: AHB-137 injection

Part1:Participants with normal liver function group

EXPERIMENTAL

Drug: AHB-137 injection

Part2:Participants with normal liver function group

EXPERIMENTAL

Drug: AHB-137 injection

Interventions

AHB-137 injection DRUG

Single use subcutaneous injection

Part1: Child-Pugh B group; Part1:Participants with normal liver function group; Part2: Child-Pugh A group; Part2:Participants with normal liver function group

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate in the study, sign an informed consent form before the study and be able to complete the study according to the requirements of the protocol;
• At the time of signing the informed consent form, male or female participants aged 18-65 years (including threshold values);
• Body mass index meets the criteria;
• Take effective contraceptive measures as required;
• Participants with liver function impairment need to meet certain liver function assessments;
• Participants with normal liver function should meet certain age, weight, and gender requirements to match those with liver function impairment, and should also undergo certain physical and laboratory tests.

You may not qualify if:

• Diagnosed or suspected liver cancer participants who have undergone liver transplantation;
• History of vasculitis or presence of signs and symptoms of potential vasculitis or laboratory tests;
• Unstable control of hypertension or diabetes, progressive nervous system disease, history of immune related extrahepatic diseases, and unstable cardiac function;
• Participants with a history of malignant tumors or undergoing malignant tumor assessment;
• Screening for participants who have undergone significant trauma or surgery within the previous 3 months, as well as those who plan to undergo surgery;
• Allergic or allergic constitution to AHB-137;
• Long term regular receipt of anticoagulant or antiplatelet drugs is required;
• Those who have received any antisense oligonucleotide drugs or have been treated with siRNA drugs or interferon within the 12 months prior to screening;
• Currently using or using any immunosuppressive medication within the past 3 months prior to screening, except for short-term use or the use of topical/inhaled steroids; Individuals who have used immunomodulators and cytotoxic drugs within the 6 months prior to administration;
• Those who have a history of vaccination or a plan to receive live vaccines within one month before administration, those who have used creatine containing fitness supplements 14 days before administration, and those who have used albumin 14 days before administration;
• HIV, Syphilis positive ;
• Those who are participating in another clinical trial and have not been eluted as required;
• Positive results in urine drug screening and alcohol breath screening tests during screening;
• Those who drink excessively and consume prohibited foods and beverages before administration;
• Participants who have donated blood (or lost blood) ≥ 400 ml, received whole blood, or used red blood cell suspension within the past 3 months prior to screening; Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;

Sponsors & Collaborators

• Ausper Biopharma Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

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; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Jing Zhang

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Yuxian Huang

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu

CONTACT

0571-86959519; clinicaltrial@ausperbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 22, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)