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The Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects

Phase 1 Clinical Trial

Official title:
To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects With Fasting Single or Multiple Oral Administration

Clinical Trial Summary

This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration

Clinical Trial Description

The whole trial consisted of three parts: Part 1 was a single-center, randomized, double-blind, placebo-controlled, single-dose dose increasing safety, tolerability and pharmacokinetic test; Part 2 was a single-center, randomized, double-blind, placebo-controlled, multiple-dose safety, tolerability and pharmacokinetic study. Part 3 is a single-dose, randomized, open, two-phase, double-cross, two-sequence design trial of the effects of food on the main PK parameters of SHEN211 tablets in healthy subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06214858
Study type Interventional
Source JKT Biopharma Co., Ltd.
Contact steve Shen, ph.D
Phone 18016406196
Email steve.shen@convalife.com
Status Recruiting
Phase Phase 1
Start date December 14, 2023
Completion date April 30, 2024
View Details
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