NCT04021563

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

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics of SR419 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Shanghai SIMR Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety, tolerability, PK of SR419 in healthy volunteers.

Detailed description

This is a Phase I study to evaluate the safety, tolerability, PK of SR419 in healthy volunteers. The study will include 3 parts. Part A is a double-blind, randomized, placebo-controlled, single-dose escalation study of SR419 in healthy young subjects. Part B is a double-blind, randomized, placebo-controlled, repeated-dose escalation study of SR419 in healthy young subjects. Part C is a double-blind, randomized, placebo-controlled, repeated dose study of SR419 in healthy elderly subjects.

Conditions

• Healthy Volunteers

Interventions

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

Timeline

• Start date: 2019-07-26
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2019-07-16
• Last updated: 2024-11-29

Locations

1 site across 1 country: Australia