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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Ausper Biopharma Co., Ltd.The sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07600788
- Acronym / sponsor ID
- AB-10-8010
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ausper Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHB-137 injectionSingle use subcutaneous injection | Drug | Part1: Child-Pugh B group, Part1:Participants with normal liver function group, Part2: Child-Pugh A group, Part2:Participants with normal liver function group |
Primary outcome
Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax)
Time frame: 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)
Time frame: Up to day 29
6 secondary outcomes
PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last)
Time frame: Up to day 29
PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24)
Time frame: Up to day 29
PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168)
Time frame: Up to day 29
PK parameter: D8 blood concentration (C168)
Time frame: Up to day 29
PK parameter: peak time (Tmax)
Time frame: Up to day29
Safety indicators
Time frame: Up to day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Zhang principal investigator
Huashan Hospital
Yuxian Huang principal investigator
Huashan Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu (0571-86959519, clinicaltrial@ausperbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax) (time frame: Up to day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.