A Study to Evaluate the Safety, Tolerability, and PK in Healthy Volunteers and HCV Genotype 1 Infected Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

April 30, 2012

Study Completion Date

July 31, 2013

Conditions
HealthyHepatitis C, Chronic
Interventions
DRUG

TG-2349

Supplied as oral liquid formulation in pre-filled glass syringe. Two dose strengths, 25 mg TG-2349 (25 mg/mL in PEG 400, 1.1 mL fill) and 200 mg TG-2349 (50 mg/mL in PEG 400, 4.1 mL fill), are filled into 5-mL type 1 glass syringes. Required doses during clinical study are to be dispensed using the combination of the two dose units. The entire content of the syringe is to be taken by mouth.

DRUG

placebo

Available in two different unit doses, 1.1 mL and 4.1 mL PEG 400 in 5-mL type 1 glass syringes. They are identical in appearance and similar in weight to TG-2349 oral liquid syringes.

Trial Locations (1)

90630

WCCT, Cypress

All Listed Sponsors
lead

TaiGen Biotechnology Co., Ltd.

INDUSTRY

NCT01523990 - A Study to Evaluate the Safety, Tolerability, and PK in Healthy Volunteers and HCV Genotype 1 Infected Patients | Biotech Hunter | Biotech Hunter