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
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.
- 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