drugset / Trial / NCT04464239

A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy Participants

NCT04464239

Phase 1 Completed 28 enrolled Taisho Pharmaceutical R&D Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in healthy volunteers. This Phase I study is composed of two parts; Part A (Single Ascending Dose) and Part B (Repeated Dose). The study employs a randomized, double-blind, placebo-controlled, parallel group design to evaluate the single and repeat-dose safety and pharmacokinetics of TS-142 in healthy participants.

Timeline

Start
2020-09-14
Primary completion
2021-01-21
Completion
2021-01-21

Drugs

EvaluationDrugModalityDoseRoute
Subject TS-142 Small molecule 10 mg Oral
Subject TS-142 Small molecule 20 mg Oral
Subject TS-142 Small molecule 30 mg Oral

Indications

No indication recorded.