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A Phase I Study of TS-172 in Healthy Adult Subjects (Single and Multiple Doses)

NCT04979572 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-02-28

No results posted yet for this study

Summary

A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

TS-172

* Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting) * Multiple dose of TS-172 90 mg before breakfast and dinner

DRUG

Placebo

* Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2) * Multiple dose of TS-172 placebo before breakfast and dinner

Sponsors & Collaborators

  • Taisho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Taisho Director · Taisho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2022-01-26
Completion
2022-01-26

Countries

  • Japan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04979572 on ClinicalTrials.gov