NCT05083468

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

A Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SR750 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Shanghai SIMR Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety, tolerability, and PK of SR750 in healthy volunteers.

Detailed description

This study is a randomized, double-blinded, placebo-controlled, 2-part Phase I study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of SR750 in healthy volunteers. This study includes 2 parts: Part A is a double-blind, randomized, placebo-controlled, single-dose escalation study of SR750 in healthy volunteers. Part B is a double-blind, randomized, placebo-controlled, repeated-dose escalation study of SR750 in healthy volunteers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SR750 tablet	The volunteers will be orally administrated by single or multiple dose of SR750 tablet with 240 mL water.
DRUG	matching placebo	The volunteers will be orally administrated by single or multiple dose of matching placebo with 240 mL water.

Timeline

• Start date: 2021-10-29
• Primary completion: 2022-10-14
• Completion: 2022-10-14
• First posted: 2021-10-19
• Last updated: 2024-11-29

Locations

1 site across 1 country: Australia