Study S001508

A Phase I Clinical Study Comparing the Relative Bioavailability, Safety and Tolerability of the First-generation and Second-generation Formulations of HRS9531 Tablets and Exploring the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Escalation of the Second-generation Formulation

ClinicalTrials.gov record

Registration

Registration: NCT07150962
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: RECRUITING
Enrollment: 168
Start: 2025-10-15
Primary completion: 2026-02
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions: Overweight or Obesity
Interventions: DRUG:HRS-9531 Tablet
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

Area under the curve from Time Zero to Time of last quantifiable concentration (AUCtau) [From Day 14 to Day 15.]
Adverse event (AE) [Screening period up to Day 35.]
Serious adverse event (SAE) [Screening period up to Day 35.]

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