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.

  • STATUS
    Recruiting
  • participants needed
    66
  • sponsor
    TaiGen Biotechnology Co., Ltd.
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Updated on 19 February 2024
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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.

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 PK of single oral dose of TG-1000 in healthy subjects.

Details
Condition Healthy Chinese Volunteers
Age 18years - 45years
Treatment Placebo, TG-1000
Clinical Study IdentifierNCT04495322
SponsorTaiGen Biotechnology Co., Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'Willing to provide written informed consent.'
b'Age 18 (or legal adult age) to 45 years.'
b'Body mass index (BMI) in the range of \\u226519.0 to \\u2264 24.0 kg/m2 and body weight \\u2265 50 kg'
b'for male and \\u2265 45 kg for female at Screening.'
b'Subjects have good communication with Investigator and agree to follow the study'
b'requirement to complete study.'

Exclusion Criteria

b'Clinically significant abnormality in 12-lead ECG, chest X-ray, abdominal ultrasounds,'
b'physical examination, vital signs or laboratory values at Screening or Day-1.'
b'Positive breath alcohol or urine drug tests at Day-1.'
b'Positive test results for IgM anti-HAV antibody, HBsAg, anti-HCV antibody, HIV or'
b'yphilis at Screening.'
b'Female subjects with positive pregnancy test results at Screening or Day-1.'
b'Male subjects are unwilling to use effective contraception and refrain from sperm'
b'donation from Screening until 3 months after the study drug administration.'
b'Current or prior history of any of the following:'
b'Significant cardiac disease, diabetes, liver, kidney disease, psychiatric'
b'diseases or drug abuse or diseases that will affect immunity.'
b'Difficulty in swallow or gastrointestinal disorder that could interfere with the'
b'absorption of the study drug'
b'Difficulty in blood sampling or venipuncture'
b'Drug allergy or hypersensitivity'
b'Blood donation \\u2265 400mL within 3 months before and after study.'
b'Alcoholics or frequent drinkers prior to Screening.'
b'Frequent smokers prior to Screening.'
b'Use of any prohibited medications or surgeries prior to study drug administration:'
b'a. Received any other investigational agents or devices, liver enzyme inducer or'
b'inhibitors, medications including prescriptions, non-prescriptions or herbal remedies,'
b'dietary supplements or surgeries.'
b'Unwilling to abstain from alcohol, tobacco, nicotine containing products, caffeine- or'
b'xanthine-containing beverages from Screening until discharge from the phase I unit.'
b'Subjects may not be qualified for the study judged by the Investigator.'
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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