Study S001517

A Single-center, Single-dose, Randomized, Open-label, Single-period, Parallel Bioequivalence Study of HRS9531 Injection Solution in Multi-dose Pens and Single-dose Pens in Overweight/Obese Subjects

ClinicalTrials.gov record

Registration

Registration: NCT06792955
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 120
Start: 2025-02-11
Primary completion: 2025-06-06
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions: Overweight/Obesity
Interventions: DRUG:HRS9531 injection
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

The maximum plasma concentration (Cmax) [Post-dose at day 1 to day 43.]
Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast) [Post-dose at day 1 to day 43.]
Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf) [Post-dose at day 1 to day 43.]

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