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.

Overview

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 Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2020

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 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.

Interventions

  • Drug: TG-1000
    • Subjects in cohort A1 will receive one single oral dose of TG-1000 under fasted condition. Subjects in cohort A2-A6 will receive one single oral dose of TG-1000 or Placebo under fasted condition. Subjects in cohort B1 and B2 will receive the optimal dose of TG-1000, based on the preliminary results of Part A, and they will be equally randomized to Cohort B1 or Cohort B2 according to a classical two-sequence [treatment sequence AB (where the subjects will first receive treatment A and then treatment B) and sequence BA (where the subjects will first receive treatment B and then treatment A)], two-period (Session 1 or Session 2) crossover design to receive the active treatment of TG-1000.
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Cohort A1
    • 2 x 5-mg TG-1000 capsules
  • Experimental: Cohort A2
    • 1 x 20-mg TG-1000 capsule or Placebo capsule
  • Experimental: Cohort A3
    • 2 x 20-mg TG-1000 capsules or Placebo capsules
  • Experimental: Cohort A4
    • 4 x 20-mg TG-1000 capsules or Placebo capsules
  • Experimental: Cohort A5
    • 6 x 20-mg TG-1000 capsules or Placebo capsules
  • Experimental: Cohort A6
    • 8 x 20-mg TG-1000 capsules or Placebo capsules
  • Experimental: Cohort B1
    • Section 1: Day 1: Treatment X mg TG-1000 (fasted) Wash-out Section 2:Day 1: Treatment X mg TG-1000 (fed)
  • Experimental: Cohort B2
    • Section 1: Day 1: Treatment X mg TG-1000 (fed) Wash-out Section 2:Day 1: Treatment X mg TG-1000 (fasted)

Clinical Trial Outcome Measures

Primary Measures

  • AEs
    • Time Frame: 8 days
    • Adverse events
  • blood pressure (mmHg)
    • Time Frame: 8 days
    • Blood pressure is measured by sphygmomanometer. Any significant findings after dosing will be considered as adverse events.
  • pulse/heart rate (beats/min)
    • Time Frame: 8 days
    • Heart rate is measured by sphygmomanometer. Any significant findings after dosing will be considered as adverse events.
  • respiratory rate (breaths/min)
    • Time Frame: 8 days
    • Respiratory rate is measured by site staff. Any significant findings after dosing will be considered as adverse events.
  • body temperature (℃)
    • Time Frame: 8 days
    • Body temperature is measured by site thermometer. Any significant findings after dosing will be considered as adverse events.
  • Number of Participants 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.
  • heart rate (ECG)
    • Time Frame: 8 days
    • Any significant findings after dosing will be considered as adverse events.
  • RR (ECG)
    • Time Frame: 8 days
    • Any significant findings after dosing will be considered as adverse events.
  • PR (ECG)
    • Time Frame: 8 days
    • Any significant findings after dosing will be considered as adverse events.
  • QRS (ECG)
    • Time Frame: 8 days
    • Any significant findings after dosing will be considered as adverse events.
  • QT (ECG)
    • Time Frame: 8 days
    • Any significant findings after dosing will be considered as adverse events.
  • QTcB (ECG)
    • Time Frame: 8 days
    • Any significant findings after dosing will be considered as adverse events.
  • QTcF (ECG)
    • Time Frame: 8 days
    • Any significant findings after dosing will be considered as adverse events.
  • Holter ECG 12 hr pre-dose until 24 hr post-dose
    • Time Frame: 12 hr pre-dose until 24 hr post-dose
    • Any significant findings after dosing will be considered as adverse events.
  • Number of Participants With Abnormal Laboratory Values
    • Time Frame: 8 days
    • Chemistry, Hematology, Coagulation, Urinalysis, HIV, HAV, HBV, HCV, syphilis, serum pregnancy tests and Breath Alcohol Test
  • Cmax
    • Time Frame: 15 days
    • Maximum plasma concentration
  • Tmax
    • Time Frame: 15 days
    • Time to Cmax
  • AUC0-t
    • Time Frame: 15 days
    • Area under the curve from time zero to the time
  • AUC0-last
    • Time Frame: 15 dys
    • Area under the concentration-time curve from time zero to the last quantifiable concentration
  • AUC0-inf
    • Time Frame: 15 days
    • Area under the concentration-time curve from time zero to infinity
  • T1/2, z
    • Time Frame: 15 days
    • Terminal elimination half-life
  • CL/F
    • Time Frame: 15 days
    • Apparent total body clearance
  • V/F
    • Time Frame: 15 days
    • Apparent total volume distribution
  • C24
    • Time Frame: 15 days
    • Plasma concentration 24 h after dosing
  • Feu0-t
    • Time Frame: 15 days
    • Urinary excretion ratio relative to dose from time zero to the time

Participating in This Clinical Trial

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 IgM 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 ≥ 400mL 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • TaiGen Biotechnology Co., Ltd.
  • Collaborator
    • R&G Pharma Studies Co.,Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pingsheng Xu, Principal Investigator, Xiangya Hospital of Central South University
  • Overall Contact(s)
    • YI-CHIN HUANG, +886-2-81777020, ychuang@taigenbiotech.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.