Status:
COMPLETED
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.
Lead Sponsor:
TaiGen Biotechnology Co., Ltd.
Collaborating Sponsors:
R&G Pharma Studies Co.,Ltd.
Conditions:
Healthy Chinese Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 do...
Detailed 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 v...
Eligibility Criteria
Inclusion
- Willing to provide written informed consent.
- Age 18 (or legal adult age) to 45 years.
- 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.
- Subjects have good communication with Investigator and agree to follow the study requirement to complete study.
Exclusion
- Clinically significant abnormality in 12-lead ECG, chest X-ray, abdominal ultrasounds, physical examination, vital signs or laboratory values at Screening or Day-1.
- Positive breath alcohol or urine drug tests at Day-1.
- Positive test results for Immunoglobulin M anti-HAV antibody, HBsAg, anti-HCV antibody, HIV or syphilis at Screening.
- Female subjects with positive pregnancy test results at Screening or Day-1.
- Male subjects are unwilling to use effective contraception and refrain from sperm donation from Screening until 3 months after the study drug administration.
- Current or prior history of any of the following:
- Significant cardiac disease, diabetes, liver, kidney disease, psychiatric diseases or drug abuse or diseases that will affect immunity.
- Difficulty in swallow or gastrointestinal disorder that could interfere with the absorption of the study drug
- Difficulty in blood sampling or venipuncture
- Drug allergy or hypersensitivity
- Blood donation ≥ 400 mL within 3 months before and after study.
- Alcoholics or frequent drinkers prior to Screening.
- Frequent smokers prior to Screening.
- 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.
- Unwilling to abstain from alcohol, tobacco, nicotine containing products, caffeine- or xanthine-containing beverages from Screening until discharge from the phase I unit.
- Subjects may not be qualified for the study judged by the Investigator.
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04495322
Start Date
July 17 2020
End Date
December 30 2020
Last Update
January 7 2021
Active Locations (1)
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1
Xiangya Hospital of Central South University
Changsha, Hunan, China