NCT05012761

The Pharmacokinetics (PK), Safety, Tolerability of SR419 in Healthy Volunteers

A Phase I Bridging Study to Evaluate the PK, Safety and Tolerability of SR419 in 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 PK bridging study to evaluate the PK, safety and tolerability of SR419 in healthy subjects.

Detailed description

The study is a Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers. The study will include 3 single-ascending-dose (SAD) cohorts and 2 multiple-dose cohorts (Part A and part B respectively), a total of 5 cohorts, and each cohort includes 3 stages: screening and baseline, treatment and safety monitoring, and safety follow-up.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SR419 capsules	Ascending single and multiple doses of SR419 orally
DRUG	Placebo	Ascending single and multiple doses of placebo orally

Timeline

• Start date: 2021-08-24
• Primary completion: 2021-12-27
• Completion: 2022-05-27
• First posted: 2021-08-19
• Last updated: 2024-11-29

Locations

1 site across 1 country: China