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Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese

NCT01679028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-11-24

Study results available
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Summary

The purpose of this study is to see how safe an investigational new drug (T89) is and how well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.

Conditions

  • Healthy

Interventions

DRUG

T89 Group A

150mg single dose on day 1

DRUG

Placebo Group A

150mg single dose

DRUG

Placebo Group B

300mg single dose

DRUG

T89 Group B

300mg single dose

DRUG

Placebo Group C

225mg bid

DRUG

T89 Group C

225mg bid

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Tasly Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jason GUO, M.D. · Tasly Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-10-31
Completion
2013-02-28

Countries

  • United States

Study Locations

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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 NCT01679028 on ClinicalTrials.gov