A Phase I, Randomized, Double-blind, Placebo Controlled, Ascending Dose Study in Healthy Chinese Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) Profile of Single and Multiple Ascending Oral Doses of TG-2349
Overview
- Phase
- Phase 1
- Intervention
- Furaprevir capsule (SAD)
- Conditions
- Healthy Chinese Volunteers
- Sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Cmax (Maximum Plasma Concentration)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of different doses of TG-2349 (Furaprevir capsule) in healthy Chinese volunteers.
Detailed Description
This study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile in healthy Chinese volunteers with single or multiple ascending oral doses of TG-2349 (Furaprevir capsule). The study is separated into two parts, part A and part B. Part A：To evaluate the safety, tolerability, and PK profile of single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 in healthy Chinese volunteers. Part B：To evaluate the safety, tolerability, and PK profile of multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 for five days in healthy Chinese volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Before starting the study, an informed consent form (ICF) approved by the Institutional Review Board (IRB) is obtained from the subject or his/her legal representative；
- •Male or female, and 18 to 45 years of age inclusive when signing ICF；
- •Body mass index (BMI) in the range of 19.0 to 24.0 kg/m2 and male body weight ≥ 50 kg, female body weight ≥ 45 kg；
- •In generally good physical and mental health status on basis of a medical history review, physical examination and vital signs, 12-lead ECG, and laboratory results at screening；
- •For females, one of the following criteria must be fulfilled
- •Had undergone surgical sterilization, or
- •Subjects of childbearing potential must satisfy the following criteria:
- •Before group assignment, the pregnancy test is negative, and Subjects agree to use an approved contraceptive method (i.e. oral spermicidal agent, condoms, or intrauterine devices) during the entire study period (from signing ICF to the last visit). Subjects must also consent to keep the contraceptive method unchanged until 1 month after the study, and Breastfeeding is prohibited
- •Males must be willing to use a reliable form of contraception (use of a condom or spouses using any of the above standards) during the entire study period (from signing ICF to the last visit)；
- •Have not used tobacco or nicotine-containing products within 1 month prior to the first dose of study drug；
Exclusion Criteria
- •Current, prior history, or family history of any disease of sudden cardiac death, myocardial ischemia, myocardial infarction, congestive heart failure, QT prolongation syndrome, hypokalemia, myocarditis, exertional dyspnea, cerebrovascular injury, venous thromboembolism；
- •Requires concomitant medication associated with increased QTc interval (i.e. Class I or III antiarrhythmic agents or with cardiac insufficiency；
- •Any abnormality on 12-lead ECG: PR\>240 ms, PR\<110 ms, QRS\>110 ms, QTc\>450 ms, or bradycardia ( heart rate \< 50 beats/min) at screening or the day -1；
- •Any clinical significant abnormality on 12-lead ECG (i.e. atrioventricular block, TdT, other types of ventricular tachycardia, atrial fibrillation and ventricular flutter, clinical significant abnormality on T wave changes or any abnormality on 12-lead ECG that effects QTc intervals) at screening or the day -1；
- •Systolic pressure\>140 mmHg or \<90 mmHg, diastolic pressure \>90 mmHg, pulse \<50 beats/min or \>100 beats/min at screening or the day -1；
- •Any clinical significant abnormality on chest X-rays or abdominal ultrasound scan at screening；
- •Positive serological test for hepatitis A (IgM anti-HAV), hepatitis B (HbsAg), hepatitis C (anti-HCV antibody), or syphilis at screening；
- •Pregnant or breastfeeding；
- •Any abnormal laboratory values (normal value ±10％) that are considered clinical significant by the Investigator at screening or the day -1；
- •Positive breath alcohol test or urine drug screen at screening or the day -1；
Arms & Interventions
Furaprevir capsule (SAD)
single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule)
Intervention: Furaprevir capsule (SAD)
Placebo (SAD)
Single ascending oral dose of Furaprevir similar capsule. .
Intervention: Placebo (SAD)
Furaprevir capsule (MAD)
multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule)
Intervention: Furaprevir capsule (MAD)
Placebo (MAD)
Multiple ascending oral doses of Furaprevir similar capsule
Intervention: Placebo (MAD)
Outcomes
Primary Outcomes
Cmax (Maximum Plasma Concentration)
Time Frame: 10 days
Maximum Plasma Concentration
Tmax (Time at Which Maximum Plasma Concentration is Observed)
Time Frame: 10 days
Time at Which Maximum Plasma Concentration is Observed
AUC (Area Under the Plasma Concentration)
Time Frame: 10 days
Area Under the Plasma Concentration
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 10 days
CTCAE v4.0
Secondary Outcomes
- 12-lead ECG (electrocardiogram)(10 days)
- blood pressure (mmHg)(10 days)
- pulse (beats/ min)(10 days)
- respiratory rate (breaths/ min)(10 days)
- body temperature (oC)(10 days)
- General Appearance Physical examination(10 days)
- Skin Physical examination(10 days)
- Head and Neck Physical examination(10 days)
- Chest region Physical examination(10 days)
- Abdominal region Physical examination(10 days)
- Back region Physical examination(10 days)
- Extremities Physical examination(10 days)