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To Evaluate the Safety, Tolerability, and Pharmacokinetics Profile in Healthy Chinese Volunteers of TG-2349

NCT03610867 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-08-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of different doses of TG-2349 (Furaprevir capsule) in healthy Chinese volunteers.

Conditions

  • Healthy Chinese Volunteers

Interventions

DRUG

Furaprevir capsule (SAD)

There are four doses in this part, 100 mg, 200 mg, 400 mg, and 600 mg. Each subject will receive the sample once by oral administration.

DRUG

Furaprevir capsule (MAD)

There are three doses in this part, 200 mg, 400 mg, and 600 mg. Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.

DRUG

Placebo (SAD)

Each subject will receive the sample once by oral administration.

DRUG

Placebo (MAD)

Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.

Sponsors & Collaborators

  • R&G Pharma Studies Co.,Ltd.

    collaborator INDUSTRY

  • Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Pingsheng Xu, PhD · Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • China

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 NCT03610867 on ClinicalTrials.gov