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