Single & Multiple Ascending Dose Study of SAR443820 in Healthy Adult Participants
Status:
Completed
Trial end date:
2021-07-20
Target enrollment:
Participant gender:
Summary
This is a Phase 1, single-center study conducted in 2 parts:
Part 1a, single ascending dose (SAD-TDU16519): Double-blind, randomized, placebo-controlled
sequential ascending single oral doses including up to 6 cohorts. Each cohort will include 8
participants (6 receiving SAR443820 and 2 placebo).
Part 1b (TDU16519): - Open label, single SAR443820 dose in one or two separated cohort(s) for
SAR443820 measurements in CSF and in plasma.
Part 2, multiple ascending dose (MAD -TDR16520): Double-blind, randomized,
placebo-controlled, sequential ascending repeated oral doses for 14 days, including up to 4
cohorts. Each cohort will include 10 participants (8 receiving SAR443820 and 2 placebo).