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Tests treatment safety and results for Obesity
Official title A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-5817 Injection
ClinicalTrials.gov ID: NCT06934408
What this study is testing
What is HRS-5817 Injection?
HRS-5817 Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to...
- Males or females aged 18-55 years old (inclusive).
- people who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests and...
- Body weight change (difference between the maximum body weight and the minimum body weight within 3 months) of no more than 5 kg within the past 3...
- Female people of childbearing potential must agree to take highly effective contraceptive measures and avoid egg donation from the signing of the...
You likely can't join if
- Known or suspected allergy to any ingredient in the investigational medicinal products or related products; or history of multiple and/or severe...
- History of or suffering from major diseases of cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory...
- people who have had severe trauma or undergone major surgical procedures within 6 months before screening, or who plan to undergo surgery during the...
- people who have participated in and used any other clinical trial drugs or medical device treatments within 3 months prior to screening or plan to do...
- Significant changes in diet and exercise habits within 1 month before screening, or failure to maintain a basically stable lifestyle such as diet and...
- Known or suspected history of drug abuse or substance abuse, or positive urine drug screening during the screening period.
See the full eligibility criteria
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study...
- Males or females aged 18-55 years old (inclusive).
- people who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests and electrocardiogram (ECG) results.
- Body weight change (difference between the maximum body weight and the minimum body weight within 3 months) of no more than 5 kg within the past 3 months.
- Female people of childbearing potential must agree to take highly effective contraceptive measures and avoid egg donation from the signing of the informed consent form to 6 months after the last dose, and must have a...
- Known or suspected allergy to any ingredient in the investigational medicinal products or related products; or history of multiple and/or severe allergies to drugs or food, or history of severe anaphylaxis.
- History of or suffering from major diseases of cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory, blood, immune or genitourinary systems, which are not suitable for...
- people who have had severe trauma or undergone major surgical procedures within 6 months before screening, or who plan to undergo surgery during the study.
- people who have participated in and used any other clinical trial drugs or medical device treatments within 3 months prior to screening or plan to do so during the study period, or within 5 half-lives of the...
- Significant changes in diet and exercise habits within 1 month before screening, or failure to maintain a basically stable lifestyle such as diet and exercise during the study.
- Known or suspected history of drug abuse or substance abuse, or positive urine drug screening during the screening period.
- Other situations that may interfere with the evaluation of the study results or are not suitable for participating in this study as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.