The Pharmacokinetics (PK), Safety, Tolerability of SR750 (Formulation F1) in Healthy Volunteers
NCT06932536 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-12-31
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
- DRUG
-
SR750 tablet
Ascending single (30-100 mg) and multiple (30-60 mg twice daily \[b.i.d.\]) doses of SR750 orally
- DRUG
-
Ascending single and multiple doses of placebo orally
Sponsors & Collaborators
-
Shanghai SIMR Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Qian Chen · Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-04-28
- Primary Completion
- 2025-07-07
- Completion
- 2025-07-07
Countries
- China
Study Locations
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