NCT06932536

The Pharmacokinetics (PK), Safety, Tolerability of SR750 (Formulation F1) in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled Phase I Bridging Study to Evaluate the Pharmacokinetics, Safety and Tolerability of SR750 (Formulation F1) in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shanghai SIMR Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled phase I bridging study to evaluate the PK, safety and tolerability of SR750 (formulation F1) in Chinese healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SR750 tablet	Ascending single (30-100 mg) and multiple (30-60 mg twice daily \[b.i.d.\]) doses of SR750 orally
DRUG	Placebo	Ascending single and multiple doses of placebo orally

Timeline

• Start date: 2025-04-28
• Primary completion: 2025-07-07
• Completion: 2025-07-07
• First posted: 2025-04-17
• Last updated: 2025-12-31

Locations

1 site across 1 country: China