Chronic Hepatitis B VirusPhase 1NCT07884864
A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants
A Phase 1 study testing AHB-121 in people with Chronic Hepatitis B Virus, run by Ausper Biopharma Co., Ltd. at 1 site in China.
Trial summary
This is a clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AHB-121 injection in healthy and chronic hepatitis B participants. 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 Virus
- What is being tested?
- AHB-121
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2026to 29 Feb 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
- Sign the informed consent form and be able to complete the research as required.
- Age and weight meet the requirements.
- During the screening, the results of physical examination, vital signs, laboratory tests, electrocardiogram, etc. are normal or have no clinical significance(healthy individuals).
- Take effective contraceptive measures as required.
- During the screening, HBsAg, HBV DNA, ALT, and HBeAg meet certain indicators (CHB participants).
Who cannot join
- Have a serious systemic disease or a history of malignant tumor.
- Have other liver diseases besides chronic HBV infection, or have liver dysfunction, significant liver fibrosis/ cirrhosis, history of liver cell carcinoma or suspected cases.
- Have autoimmune diseases or diseases with a risk of immune activation.
- Have a questionable allergy to the test drugs and their components, or have an allergic constitution.
- Participate in other clinical trials or receive investigational drug treatment within the specified time before screening, and have received related drug
- Have received solid organ transplantation or hematopoietic stem cell transplantation before screening.
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- Have acute infection, major trauma or major surgery with clinical significance that has not fully recovered within the specified time before screening, or have a surgical plan during the study.
- Have abnormal laboratory tests, vital signs or electrocardiogram results during screening and have clinical significance as judged by the researcher.
- Have positive screening for related infectious diseases.
- Have a history of drug abuse or alcoholism; or have a large amount of smoking before screening and cannot stop during the study.
- Have consumed caffeine, xanthine-containing foods or beverages, or engaged in intense exercise within the specified time before administration, or have been unable to stop during the study.
- Have positive urine drug screening or alcohol breath test during screening; have donated blood or lost a large amount of blood before screening, received blood transfusion, or have a blood donation plan during the study.
- Have a positive pregnancy test during screening.
- Abnormal skin at the injection site.
- Have a history of fainting or hemisomnia, difficulty in blood collection, or inability to tolerate venipuncture blood collection.
- The researcher considers that there are other factors that make one unsuitable to participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Qing Xie
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-121 Injection in Healthy and Chronic Hepatitis B Participants
This is a clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AHB-121 injection in healthy and chronic hepatitis B participants.
- Conditions
- Chronic Hepatitis B Virus
- Being tested
- AHB-121, Placebo
- Keywords
- chronic hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHB-121Drug
AHB-121 will be used per week
PlaceboDrug
Placebo will be used per week
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants group | Experimental | Not described Receives: Drug: AHB-121; Drug: Placebo |
| CHB group | Experimental | Not described Receives: Drug: AHB-121; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety indicators
Incidence and severity of TEAE/SAE; changes in laboratory tests, ECG, physical examination, and vital signs compared to baseline
Measured: Up to 18weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion29 Feb 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 B VirusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Xie, Principal investigator, Ruijin HospitalJing Sun, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884864
- Sponsor's protocol ID
- AB-12-101
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-121 Injection in Healthy and Chronic Hepatitis B Participants
- ClinicalTrials.gov ID
- NCT07884864
- Acronym / sponsor ID
- AB-12-101
- Conditions
- Chronic Hepatitis B Virus
- Keywords
- chronic hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Ausper Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 21 Oct 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.
This is a clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AHB-121 injection in healthy and chronic hepatitis B participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants group | Experimental | Drug: AHB-121, Drug: Placebo |
| CHB group | Experimental | Drug: AHB-121, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign the informed consent form and be able to complete the research as required.
- Age and weight meet the requirements.
- During the screening, the results of physical examination, vital signs, laboratory tests, electrocardiogram, etc. are normal or have no clinical significance(healthy individuals).
- Take effective contraceptive measures as required.
- During the screening, HBsAg, HBV DNA, ALT, and HBeAg meet certain indicators (CHB participants).
Key exclusion criteria (16 listed)
- Have a serious systemic disease or a history of malignant tumor.
- Have other liver diseases besides chronic HBV infection, or have liver dysfunction, significant liver fibrosis/ cirrhosis, history of liver cell carcinoma or suspected cases.
- Have autoimmune diseases or diseases with a risk of immune activation.
- Have a questionable allergy to the test drugs and their components, or have an allergic constitution.
- Participate in other clinical trials or receive investigational drug treatment within the specified time before screening, and have received related drug
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-121AHB-121 will be used per week | Drug | CHB group, Healthy participants group |
| PlaceboPlacebo will be used per week | Drug | CHB group, Healthy participants group |
Primary outcome
Safety indicators
Time frame: Up to 18weeks
Incidence and severity of TEAE/SAE; changes in laboratory tests, ECG, physical examination, and vital signs compared to baseline
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 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B Virus
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A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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Evaluation of Patients With Liver Disease
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Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
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Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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Chronic Hepatitis B
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.
Qing Xie principal investigator
Ruijin Hospital
Jing Sun principal investigator
Ruijin Hospital
1 site 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-121 in people with Chronic Hepatitis B Virus, run by Ausper Biopharma Co., Ltd. at 1 site 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 5 inclusion and 16 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (057186959519, clinicaltrial@ausperbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety indicators (time frame: Up to 18weeks). 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 21 Oct 2026.