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Completed

NCT Number: NCT04495322

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.

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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Key information

Conditions

Healthy Chinese Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xiangya Hospital of Central South University

Changsha, Hunan, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

TG-1000

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of subjects of treatment-emergent adverse events

    Time frame: 8 days

    Any significant findings after dosing will be considered as adverse events.

  2. Number of subjects of Significant Abnormal Vital Signs Findings

    Time frame: 8 days

    The systolic and diastolic blood pressure (mmHg), pulse/heart rate (beats/min), respiratory rate (breaths/min), and body temperature (oC) will be measured.

  3. Number of subjects With Significant Abnormal Physical Examination Findings

    Time frame: 8 days.

    A full general physical examination of the major body systems (General Appearance; Dermatological including skin and nails; Head and Neck; Chest region including Heart and Lung; Abdominal region including Gastrointestinal and Gastroenterology; Back region; Extremities; Psychiatric or Neurological; Lymph nodes; Other) will be performed by investigator.

  4. Number of subjects With Significant Abnormal 12-lead Electrocardiography (ECG) Findings

    Time frame: 8 days

    12-lead ECG will be performed after a rest in a supine position. The following ECG parameters will be listed: heart rate, the time between QRS complexes (RR Interval) (ms), the beginning of the P wave to the first deflection of the QRS complex (PR Interval) (ms), first deflection of QRS complex to end of QRS complex at isoelectric line (QRS duration) (ms), first deflection of QRS complex to end of T wave at isoelectric line (QT interval) (ms), Corrected QT interval by Bazett (QTcB) (ms), and Corrected QT interval by - Fridericia (QTcF) (ms).

  5. Number of subjects With Significant Abnormal Holter Electrocardiography (ECG) Findings

    Time frame: 12 hr pre-dose until 24 hr post-dose

    Holter ECG will be monitor continue from 12 hr pre-dose until 24 hr post-dose. The Investigator will determine whether the results of the Holter monitoring are normal or abnormal.

  6. Number of Participants With Significant Abnormal Laboratory Values

    Time frame: 8 days

    Chemistry, Hematology, Coagulation, Urinalysis, Human Immunodeficiency Virus (HIV) test, Hepatitis A virus(HAV) test, Hepatitis B virus (HBV) test, Hepatitis C virus (HCV) test, syphilis, serum pregnancy tests and Breath Alcohol Test

  7. Peak Plasma Concentration (Cmax)

    Time frame: 15 days

    Blood sample will be collected to evaluate PK profile and food effect of TG-1000.

  8. time to Cmax (Tmax)

    Time frame: 15 days

    Blood sample will be collected to evaluate PK profile of TG-1000.

  9. area under the curve from time zero to the time (AUC0-t)

    Time frame: 15 days

    Blood sample will be collected to evaluate PK profile and food effect of TG-1000.

  10. area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)

    Time frame: 15 days

    Blood sample will be collected to evaluate PK profile of TG-1000.

  11. area under the concentration-time curve from time zero to infinity (AUC0-inf)

    Time frame: 15 days

    Blood sample will be collected to evaluate PK profile and food Effect of TG-1000.

  12. terminal elimination half-life (T1/2, z)

    Time frame: 15 days

    Blood sample will be collected to evaluate PK profile of TG-1000.

  13. apparent total body clearance (CL/F)

    Time frame: 15 days

    Blood sample will be collected to evaluate PK profile of TG-1000.

  14. apparent total volume distribution (V/F)

    Time frame: 15 days

    Blood sample will be collected to evaluate PK profile of TG-1000.

  15. plasma concentration 24 h after dosing (C24)

    Time frame: 15 days

    Blood sample will be collected to evaluate PK profile of TG-1000.

  16. urinary excretion ratio relative to dose from time zero to the time (Feu0-t)

    Time frame: 15 days

    Urine sample will be collected to evaluate PK profile of TG-1000.

Sponsors and collaborators

Lead sponsor

TaiGen Biotechnology Co., Ltd.

Industry

Collaborators

  • R&G Pharma Studies Co.,Ltd.

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2020
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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