A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2024
The present study is a randomized, placebo-controlled, parallel study. 250 participants will be screened, and considering a screening failure rate of 20%, approximately 200 participants will be randomized in a ratio of 1:1:1:1:1 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code. Each group will have at least 30 participants (total 150 completers) after accounting for a dropout/withdrawal rate of 25%. The intervention duration for all the study participants is 180 days.
Epistemonikos ID: 9e94b250316b755b08f0c26b201fb0e28346309b
First added on: Jul 01, 2024