A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered HRS9531

HRS9531-101

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple subcutaneous injections of HRS9531 in healthy subjects.

2021-12-06

2022-08-24

2022-08-24

Completed

Early phase I

90

Inclusion Criteria: 1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent; 2. Age 18-55 years on the date of signing informed consent (inclusive); 3. Body weight ≥50 kg, body mass index (BMI) within the range of 19.0-35.0 kg/m2 (inclusive); 4. Subjects with good general health, no clinically significant abnormalities. Exclusion Criteria: 1. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study; 2. Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period; 3. Participants in clinical trials of any drug or medical device in the 3 months prior to screening; 4. Blood donation history or blood loss ≥400 mL within 1 month before screening, or received blood transfusion within 2 months; 5. Allergic constitution includes severe drug allergy or history of drug allergy; 6. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive; 7. Breast-feeding women; 8. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'HRS9531 compared with placebo', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

2022-09-19