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NCT07884864Not yet recruitingPhase 1

A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-121 Injection in Healthy and Chronic Hepatitis B Participants

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

This is a clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AHB-121 injection in healthy and chronic hepatitis B participants.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
110 (estimated)
First submitted
14 Oct 2026
Start date
28 Oct 2026
Primary completion date
30 Apr 2027
Lead sponsor
Ausper Biopharma Co., Ltd.
Diseases
Hepatitis B
NCT number
NCT07884864

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 110
  • From 28 Oct 2026 to the primary completion date, 30 Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • 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.
  • 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 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 a history of fainting or hemisomnia, difficulty in blood collection, or inability to tolerate venipuncture blood collection.

Lab values

  • Have abnormal laboratory tests, vital signs or electrocardiogram results during screening and have clinical significance as judged by the researcher.

Other

  • 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 a positive pregnancy test during screening.
  • Abnormal skin at the injection site.
  • The researcher considers that there are other factors that make one unsuitable to participate in this trial.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.