Clinilabs, a contract research organization (CRO), was selected to characterize the pharmacokinetic prole of XXXX following the administration of four doses of XXXX to healthy Japanese and non-Japanese subjects aged 20 to 45 years by assessing serum concentration data over time.
Up to 100 subjects (50 per group) are planned to be enrolled, with up to 10 subjects/group per dose level completing the study. Clinilabs enrolled 11 Japanese and 11 Caucasian subjects in the trial in 12 weeks, exceeding our initial target enrollment. Based on our performance, the sponsor requested that we enroll 6 additional subjects.
The sponsor faced several challenges to study enrollment that they turned to Clinilabs to overcome