Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-5817 Injection
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-11-17
92
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5817 when administered subcutaneously (SC) as single and multiple doses in adults who are affected by obesity.
CONDITIONS
Official Title
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-5817 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and agree to follow study procedures
- Male or female aged 18 to 55 years old
- Generally healthy based on medical history, vital signs, physical exam, lab tests, and ECG
- Body weight stable with no more than 5 kg change in past 3 months
- Female participants of childbearing potential must use effective contraception and have a negative pregnancy test before dosing
- Male participants with partners of childbearing potential must use effective contraception and avoid sperm donation from consent to 6 months after last dose
You will not qualify if you...
- Known or suspected allergy to study drug ingredients or severe allergies/anaphylaxis history
- Major diseases of cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory, blood, immune, or genitourinary systems judged unsuitable
- Severe trauma or major surgery within 6 months before screening or planned surgery during study
- Use of other clinical trial drugs or medical devices within 3 months before screening or planned use during study
- Significant changes in diet or exercise within 1 month before screening or inability to maintain stable lifestyle during study
- History or suspicion of drug or substance abuse or positive drug screening at screening
- Other conditions judged unsuitable by investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Hospital of Anhui Medical Uniersity
Hefei, Anhui, China, 230601
Actively Recruiting
Research Team
S
Sheng Feng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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