Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Injections of HRS-5817 Injection in Healthy Adult Volunteers With or Without Obesity
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-11-17
92
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of an investigational drug called HRS-5817 in adults affected by obesity. This Phase I study involves healthy adult volunteers with or without obesity and aims to understand how the body processes this drug and how the drug affects the body. Participants will receive HRS-5817 injection or a placebo, both administered under the skin (subcutaneously) either as single or multiple doses. The study uses a randomized, quadruple-blind design to compare the effects of the drug versus placebo. The treatment period and monitoring extend up to about 253 days after dosing to closely observe drug behavior and safety. During the study, participants will undergo medical evaluations including vital signs, physical exams, lab tests, and electrocardiograms. Researchers will monitor for adverse events and measure drug levels in the body over time. Participants will be followed up regularly to assess drug clearance, immune response, and overall safety. The total study duration includes screening, treatment, and extended observation periods to ensure thorough assessment.
CONDITIONS
Brief 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 informed consent and agree to follow the study protocol
- Male or female aged 18 to 55 years inclusive
- Generally healthy as judged by medical history, vital signs, physical exam, lab tests, and ECG
- Body weight change no more than 5 kg within the past 3 months
- Female participants of childbearing potential must use effective contraception and have a negative pregnancy test before dosing; must not be breastfeeding
- 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 investigational drug ingredients or severe allergies/anaphylaxis history
- History or presence of major cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory, blood, immune, or genitourinary diseases
- Severe trauma or major surgery within 6 months before screening or planned surgery during the study
- Participation in other clinical trials or use of investigational drugs/devices within 3 months before screening or during study, or within 5 half-lives of investigational drug
- 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 urine drug screening at screening
- Other conditions that may interfere with study evaluation or judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 253 days
Participants receive single or multiple subcutaneous injections of the study drug or placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits for dosing and assessments over the treatment period
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here