Chronic Hepatitis BPhase 1NCT07600788
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.
A Phase 1 study testing AHB-137 injection in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- AHB-137 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesChina
- Study dates
- 9 Jul 2026to 15 May 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Participants with thyroid dysfunction who are not suitable for inclusion in the study;
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- 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;
- Long term regular vigorous exercise or intense exercise within 48 hours before screening;
- Any other circumstances or conditions that the researcher deems unsuitable for the subject to participate in this study;
- Diseases that need to be excluded according to the merger plan for patients with abnormal liver function;
- The laboratory test results do not meet the requirements of the protocol;
- Participants with normal liver function who have a history of chronic liver disease or known liver or biliary abnormalities;
- Participants with normal liver function who have used traditional Chinese medicine or other systemic medications with potential liver toxicity 14 days before administration;
- Participants with normal liver function and abnormal QTcF values.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality
Caihong Li, 021-52888921, licaihong199505@163.com
Jing Zhang
- Not yet recruiting
AusperBio Investigational Site
Zhengzhou, Henan
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
About this study
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
- Being tested
- AHB-137 injection
- Keywords
- Hepatitis B, Chronic
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHB-137 injectionDrug
Single use subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Part1: Child-Pugh B group | Experimental | Not described Receives: Drug: AHB-137 injection |
| Part2: Child-Pugh A group | Experimental | Not described Receives: Drug: AHB-137 injection |
| Part1:Participants with normal liver function group | Experimental | Not described Receives: Drug: AHB-137 injection |
| Part2:Participants with normal liver function group | Experimental | Not described Receives: Drug: AHB-137 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax)
Measured: 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)
Measured: 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)
Measured: Up to day 29
PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24)
Measured: Up to day 29
PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168)
Measured: Up to day 29
PK parameter: D8 blood concentration (C168)
Measured: Up to day 29
PK parameter: peak time (Tmax)
Measured: Up to day29
Safety indicators
The proportion of participants who experienced all adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESIs) during the treatment period after a single subcutaneous administration of AHB-137 injection; And laboratory tests, 12 lead ECG, and changes in vital signs compared to baseline.
Measured: Up to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start9 Jul 2026
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, Principal investigator, Huashan HospitalYuxian Huang, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600788
- Sponsor's protocol ID
- AB-10-8010
- Status last verified
- Jul 2026
- First submitted
- 14 May 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No