Clinical trial 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.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Chinese Volunteers
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: R&G Pharma Studies Co.,Ltd.
First posted: 2020-07-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, randomized, double-blind, placebo-controlled, single-dose
Primary purpose: BASIC_SCIENCE

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 dose of TG-1000 in healthy volunteers.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects of treatment-emergent adverse events
timeFrame: 8 days
measure: Number of subjects of Significant Abnormal Vital Signs Findings
timeFrame: 8 days
measure: Number of subjects With Significant Abnormal Physical Examination Findings
timeFrame: 8 days.
measure: Number of subjects With Significant Abnormal 12-lead Electrocardiography (ECG) Findings
timeFrame: 8 days
measure: Number of subjects With Significant Abnormal Holter Electrocardiography (ECG) Findings
timeFrame: 12 hr pre-dose until 24 hr post-dose
measure: Number of Participants With Significant Abnormal Laboratory Values
timeFrame: 8 days
measure: Peak Plasma Concentration (Cmax)
timeFrame: 15 days
measure: time to Cmax (Tmax)
timeFrame: 15 days
measure: area under the curve from time zero to the time (AUC0-t)
timeFrame: 15 days
measure: area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
timeFrame: 15 days
measure: area under the concentration-time curve from time zero to infinity (AUC0-inf)
timeFrame: 15 days
measure: terminal elimination half-life (T1/2, z)
timeFrame: 15 days
measure: apparent total body clearance (CL/F)
timeFrame: 15 days
measure: apparent total volume distribution (V/F)
timeFrame: 15 days
measure: plasma concentration 24 h after dosing (C24)
timeFrame: 15 days
measure: urinary excretion ratio relative to dose from time zero to the time (Feu0-t)
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Pingsheng Xu
role: PRINCIPAL_INVESTIGATOR
References: