NCT05026008

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375

A Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of SR1375 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Shanghai SIMR Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SR1375 in healthy volunteers

Detailed description

This study is a phase 1,randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SR1375 in healthy volunteers. The study is divided into two parts, Part A (single ascending dose \[SAD\]) and Part B (multiple ascending dose \[MAD\]). In Part A, the scheduled dose cohorts include 1, 3, 10, 30, 100, and 200 mg; in Part B, the planned dose range will be 5, 15, and 50 mg.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SR1375	The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water
DRUG	Matching placebo	The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water

Timeline

• Start date: 2021-09-30
• Primary completion: 2022-11-30
• Completion: 2023-03-30
• First posted: 2021-08-30
• Last updated: 2024-11-29

Locations

1 site across 1 country: Australia