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Not Yet Recruiting NCT07884864

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

Conditions: Chronic Hepatitis B Virus

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 110
Sponsor: Ausper Biopharma Co., Ltd.

Location: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality

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.

Eligibility Criteria

Inclusion Criteria: * 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). Exclusion Criteria: * 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. * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07884864). StuddyBuddy aggregates publicly available trial information.