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.

TaiGen Biotechnology

Status and phase: Completed; Phase 1

Conditions: Healthy Chinese Volunteers

Treatments: Drug: Placebo; Drug: TG-1000

Study type: Interventional

Funder types: Industry

Identifiers

NCT04495322

TG-1000-C-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 8 patient groups

10 mg TG-1000

Experimental group

Description:

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

Treatment:

Drug: TG-1000

20 mg TG-1000 or Placebo

Experimental group

Description:

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

Treatment:

Drug: TG-1000

Drug: Placebo

40 mg TG-1000 or Placebo

Experimental group

Description:

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.

Treatment:

Drug: TG-1000

Drug: Placebo

80 mg TG-1000 or Placebo

Experimental group

Description:

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.

Treatment:

Drug: TG-1000

Drug: Placebo

120 mg TG-1000 or Placebo

Experimental group

Description:

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.

Treatment:

Drug: TG-1000

Drug: Placebo

160 mg TG-1000 or Placebo

Experimental group

Description:

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.

Treatment:

Drug: TG-1000

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: TG-1000

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

Experimental group

Description:

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.

Treatment:

Drug: TG-1000