MedTrace Logo

To Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and the Food Effect on Pharmacokinetics of Single Oral Dose of TG-1000 in Healthy Volunteers.

NCT04495322 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-01-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics profiles of TG-1000 in healthy volunteers, and to evaluate the food effect on pharmacokinetics of single oral dose of TG-1000 in healthy volunteers.

Conditions

  • Healthy Chinese Volunteers

Interventions

DRUG

TG-1000

Subjects will receive one single oral dose of TG-1000 on day 1 following protocol requirements.

DRUG

Placebo

Subjects will receive one single oral dose of placebo on day 1 following protocol requirements.

Sponsors & Collaborators

  • R&G Pharma Studies Co.,Ltd.

    collaborator INDUSTRY

  • TaiGen Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Pingsheng Xu · Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2020-11-26
Completion
2020-12-30

Countries

  • China

Study Locations

More Related Trials

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 NCT04495322 on ClinicalTrials.gov