This is an open label, dose ranging, phase1a/1b clinical trial to study the safety, Pharmacokinetics and Pharmacodynamics of Peglamda 60, 120, 180 and 240 mcg in healthy volunteers and antiviral activity of once weekly Peglamda administration in combination with daily Ribavirin in Hepatitis C naive patients up to 4 weeks period. The objective of the study to establish safety, PK/PD data on healthy subjects and preliminary efficacy and safety in Hepatitis C naive patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Military 108 Hospital
Hanoi, Vietnam
Area Under the Concentration-Time Curve (AUC 0-336)
Time frame: 0, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 336 hours
Percentage of Patients achieving Rapid Virological Response (RVR)
Time frame: 4 weeks
Number of subjects with incidence of adverse events
Time frame: 15 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.