A Clinical Phase I Study on GIC-1001 in Healthy Volunteers
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
The objectives of this single center, randomized, double-blinded, placebo-controlled Phase I
clinical study are to evaluate the safety and tolerability of five (5) single and four (4)
multiple increasing oral doses of GIC-1001 compared to placebo, and to evaluate the
pharmacokinetics of GIC-1001 following single and multiple-dose administration in 80 healthy,
18-50 years old male and female subjects. Moreover, the effect of food on the
pharmacokinetics of GIC-1001 in healthy subjects will be assessed. This study is designed
with an integrated, adaptive approach which allows the evaluation of single and multiples
doses of GIC-1001 in a progressive, overlapped fashion.