NCT07238647Active, not recruitingPhase 1
A Phase I, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Subcutaneous Administration of Single Ascending Doses of HRS-5817 in Obese Participants
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Atridia Pty Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Study Overview
Brief Summary
The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of HRS-5817 in obese participants
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants aged between 18 to 55 years of age (inclusive)
- •Participants with body mass index (BMI) between 30.0 kg/m2 (inclusive) to 40.0 kg/m2 (inclusive) at screening.
- •Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- •Negative pregnancy test for women of childbearing potential (WOCBP) at baseline. Men and WOCBP must agree to take highly effective contraceptive methods
Exclusion Criteria
- •1. History or evidence of clinically significant disorders
- •Individuals with a weight change of more than 5kg within 3 months prior to the screening.
- •Participant with a history of or current endocrine disorders that may significantly influence body weight (e.g., Cushing's syndrome, hypothyroidism, hyperthyroidism), or with obesity resulting from pharmacotherapy, monogenic mutations, or hereditary obesity syndromes.
- •Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
- •Use of any GLP-1 receptor agonists (including but not limited to Liraglutide, Beneglitide, Semaglutide, and Tirzepatide, etc.) or any other prescription medications, OTC drugs and dietary supplements for weight loss (including but not limited to Orlistat, Naltrexone/Bupropion, Phentermine/Topiramate, ect.). within 3 months prior to screening, and no planned use for the study duration.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Arms & Interventions
Experimental: HRS-5817 dose level 2
Experimental
Single dose of HRS-5817/placebo given subcutaneously (dose level 2)
Intervention: HRS-5817 (Drug)
Experimental: HRS-5817 dose level 1
Experimental
Single dose of HRS-5817/placebo given subcutaneously (dose level 1)
Intervention: HRS-5817 (Drug)
HRS-5817 dose level 3
Experimental
Single dose of HRS-5817/placebo given subcutaneously (dose level 3)
Intervention: HRS-5817 (Drug)
HRS-5817
Experimental
Single dose of HRS-5817/placebo given subcutaneously (dose level 4)
Intervention: HRS-5817 (Drug)
Outcomes
Primary Outcomes
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Time Frame: Day 253
Number of participants with Adverse events and Serious adverse events
Secondary Outcomes
- Pharmacokinetics - Cmax(Day 253)
- Pharmacokinetics - AUC₀-t(Day 253)
- Pharmacokinetics - Tmax(Day 253)
- Pharmacokinetics - t½(Day 253)
- Immunogenicity - Anti-Drug Antibody (ADA)(Day 253)
Investigators
Study Sites (1)
Loading locations...
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