Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-25 @ 12:19 PM
NCT ID:
NCT05188261
Pre Assignment Details:
As pre-specified by the statistical analysis plan, for the analyses reported herein, data from the 2 participants dosed with placebo in each of the 4 cohorts were pooled into a single placebo group (N=8).
Recruitment Details:
The study was designed to include up to 5 cohorts with 8 participants per cohort. Within each cohort, participants were randomized to receive a single dose of IW-3300 (6 participants) or placebo (2 participants). Doses to be evaluated were 100, 300, 900, and 2500 μg. An optional 5th cohort was planned to test an IW-3300 dose of ≤ 2500 μg. Based on a blinded review of safety and tolerability data from Cohort 1 through 4, the Dose Escalation Committee decided not to enroll the optional 5th Cohort.
Study:
NCT05188261
Study Brief:
Results Section:
NCT05188261