Status:
COMPLETED
A Trial of HRS-9813 in Healthy Volunteers
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.
Eligibility Criteria
Inclusion
- Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
- Male or female aged 18-55 (adult healthy volunteers);
- Body mass index (BMI) between 19 and 26 kg/m2;
- Normal Electrocardiogram (ECG);
- Men and women of childbearing potential must agree to take effective contraceptive methods.
Exclusion
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, urinary stones, urinary tract infection, or intestinal disorder including irritable bowel syndrome;
- History or presence of malignancy; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion;
- Seated systolic blood pressure (SBP) of \<90 mmHg or seated diastolic blood pressure (DBP) of \<60 mmHg;
- Patients with orthostatic hypotension;
- Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
Key Trial Info
Start Date :
July 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06514963
Start Date
July 24 2024
End Date
January 2 2025
Last Update
January 8 2025
Active Locations (1)
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1
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030