A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion
Status:
Recruiting
Trial end date:
2022-11-15
Target enrollment:
Participant gender:
Summary
Up to 60 healthy adult males, ≥ 18 and ≤ 55 years of age, are planned to be enrolled in the
study.
The study will consist of 6 cohorts (Cohorts 1 to 6, 1 cohort per dose level). Each cohort
will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2
subjects receiving a single dose of a matching placebo), for a total of 48 subjects planned
for evaluation. A total of 21 blood samples will be collected in each cohort for PK analysis
and a total of 14 blood samples will be collected in each cohort for PD analysis.