Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-04 @ 12:47 AM
Study NCT ID:
NCT03610867
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2018-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety, Tolerability, and Pharmacokinetics Profile in Healthy Chinese Volunteers of TG-2349
Sponsor:
Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: