Last updated: June 15, 2023
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
HRS-5635
Placebo
Clinical Study ID
NCT05808374
HRS-5635-101
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Understand the specific process of the test, voluntarily participate in the test, andsign the informed consent form in writing(In healthy people and chronic hepatitis B).
- Age 18-55 (including boundary value) (In healthy people); Age 18-65 (includingboundary value) (In chronic hepatitis B).
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) 18~28 kg/m2 (including boundary value) (In healthy people).
- Normal or abnormal vital signs, physical examination, laboratory examination, chestradiograph, etc. have no clinical significance(In healthy people).
- Subjects (including partners) are willing to voluntarily take effective contraceptivemeasures within 6 months after screening and the last study drug administration(Inhealthy people).
Exclusion
Exclusion Criteria:
- Those suffering from any clinical serious disease such as circulatory system,endocrine system, nervous system, digestive system, respiratory system, hematology,immunology, psychiatry and metabolic abnormality, or any other disease that caninterfere with the test results(In healthy people).
- Previous history of malignant tumor(In healthy people).
- Those who have digestive system disease or serious digestive system disease at presentor in the near future (within one month), and the researcher believes that it mayaffect drug absorption or have safety risk(In healthy people).
- Those who have serious infection, serious injury or major surgery within 3 monthsbefore administration; Those who plan to undergo surgery during the trial and withintwo weeks after the end of the trial(In healthy people).
- Serious cardiovascular and cerebrovascular diseases with clinical significance andunstable or uncontrolled conditions, including but not limited to myocardialinfarction, unstable angina pectoris, heart failure, and moderate stroke((In chronichepatitis B)).
- Clinically significant liver diseases caused by other causes (such as alcoholic liverdisease, nonalcoholic steatohepatitis, drug-induced liver injury, alcoholic hepatitis,etc.); (In chronic hepatitis B).
Study Design
Total Participants: 85
Treatment Group(s): 2
Primary Treatment: HRS-5635
Phase: 1
Study Start date:
April 30, 2023
Estimated Completion Date:
May 31, 2024
Connect with a study center
The First Affiliated Hospital of China University of Science and Technology
Hefei, Anhui 230001
ChinaActive - Recruiting
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