This trial will test the hypothesis that CF102 can safely and effectively suppress viral load in patients with chronic hepatitis C and high circulating levels of virus. The trial will monitor the safety of twice-daily oral dosing with CF102 over a 16-week period; will measure changes in viral load during therapy; and will measure blood concentrations of CF102 at various time points during dosing.
This is a Phase 1/2, randomized, double-blind, placebo-controlled, dose-escalation study of subjects with chronic hepatitis C genotype 1. Eligible subjects will be assigned in a 3:1 ratio (8 subjects in each cohort) to receive qd or bid treatment for 15 days with oral CF-102 or with placebo. Dose escalation will occur in 2 sequential cohorts. The decision to continue dosing within a cohort (eg, Subcohort 1a to Subcohort 1b), or to escalate to a new dose level Cohort (eg, Subcohort 1b to Subcohort 2a) will be determined by a blinded independent review of safety data. This review will be conducted by a qualified Safety Review Committee comprising the medical monitor, the consulting toxicologist, and an independent expert clinician. For the first 2 cohorts, subjects will return to the study center for follow-up assessments on Days 8, 15, and 22. Subjects dosed qd will receive a total of 15 doses of CF-102. Subjects dosed bid will receive a total of 29 doses. The 30th dose has been deleted to accommodate PK sampling on the morning of Day 16, 24 hours after the last dose of CF-102. For the 3rd cohorts, subjects will return to the study center for follow-up assessments on weeks 2, 4, 8, 12, 16 and 18.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Rabin Medical Center
Tel Aviv, Israel
Adverse Event Profile of Repeated Dosing of CF102
Time frame: 16 weeks
Effect of Viral Load
Time frame: 16 weeks
Pharmacokinetic Behavior of CF102 During Repeated Dosing
Time frame: 16 weeks
Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects
Time frame: 16 weeks
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