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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-17

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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This is a phase 1, single-center, randomized, double-blind, placebo-controlled, single-dose escalation study 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. The study will be divided into two parts.

Part A is designed as randomized, double-blind, placebo-controlled, sequential, single ascending oral dose to evaluate the safety, tolerability, and PK profiles of TG-1000 in healthy volunteers.

Part B is designed as randomized, open-label, two treatment (fasted vs. fed), two-period, two-sequence crossover to compare the effects of food on the Pharmacokinetic (PK) of single oral dose of TG-1000 in healthy subjects.

Conditions

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Healthy Chinese Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single-center, randomized, double-blind, placebo-controlled, single-dose

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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10 mg TG-1000

Eligible subjects will receive single oral dose of study drug (2 x 5-mg TG-1000 capsules)on Day 1 under fasted condition.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

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

20 mg TG-1000 or Placebo

Eligible subjects will receive single oral dose of study drug (20 mg TG-1000 capsule or Placebo capsule) on Day 1 under fasted condition.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

40 mg TG-1000 or Placebo

Eligible subjects will receive single oral dose of study drug (2 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

80 mg TG-1000 or Placebo

Eligible subjects will receive single oral dose of study drug (4 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

120 mg TG-1000 or Placebo

Eligible subjects will receive single oral dose of study drug (6 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

160 mg TG-1000 or Placebo

Eligible subjects will receive single oral dose of study drug (8 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

X mg TG-1000 (fasted)+wash-out+X mg TG-1000 (fed)

Based on the preliminary results, one optimal dose (X mg) of TG-1000 will be selected. Subject will receive a single oral dose of TG-1000 under fasted condition. After washout period, subject will receive a single oral dose of TG-1000 under fed condition.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

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

X mg TG-1000 (fed)+wash-out+X mg TG-1000 (fasted)

Based on the preliminary results, one optimal dose (X mg) of TG-1000 will be selected. Subject will receive a single oral dose of TG-1000 under fed condition. After washout period, subject will receive a single oral dose of TG-1000 under fasted condition.

Group Type EXPERIMENTAL

TG-1000

Intervention Type DRUG

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

Interventions

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TG-1000

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Willing to provide written informed consent.
2. Age 18 (or legal adult age) to 45 years.
3. Body mass index (BMI) in the range of ≥19.0 to ≤ 24.0 kg/m2 and body weight ≥ 50 kg for male and ≥ 45 kg for female at Screening.
4. Subjects have good communication with Investigator and agree to follow the study requirement to complete study.

Exclusion Criteria

1. Clinically significant abnormality in 12-lead ECG, chest X-ray, abdominal ultrasounds, physical examination, vital signs or laboratory values at Screening or Day-1.
2. Positive breath alcohol or urine drug tests at Day-1.
3. Positive test results for Immunoglobulin M anti-HAV antibody, HBsAg, anti-HCV antibody, HIV or syphilis at Screening.
4. Female subjects with positive pregnancy test results at Screening or Day-1.
5. Male subjects are unwilling to use effective contraception and refrain from sperm donation from Screening until 3 months after the study drug administration.
6. Current or prior history of any of the following:

1. Significant cardiac disease, diabetes, liver, kidney disease, psychiatric diseases or drug abuse or diseases that will affect immunity.
2. Difficulty in swallow or gastrointestinal disorder that could interfere with the absorption of the study drug
3. Difficulty in blood sampling or venipuncture
4. Drug allergy or hypersensitivity
5. Blood donation ≥ 400 mL within 3 months before and after study.
6. Alcoholics or frequent drinkers prior to Screening.
7. Frequent smokers prior to Screening.
7. Use of any prohibited medications or surgeries prior to study drug administration:

a. Received any other investigational agents or devices, liver enzyme inducer or inhibitors, medications including prescriptions, non-prescriptions or herbal remedies, dietary supplements or surgeries.
8. Unwilling to abstain from alcohol, tobacco, nicotine containing products, caffeine- or xanthine-containing beverages from Screening until discharge from the phase I unit.
9. Subjects may not be qualified for the study judged by the Investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes