Clinical Trial

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

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated December 30, 2025 (before its estimated January 5, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-06-18; most recent amendment 2025-12-22.
Status change: Not Yet Recruiting → Recruiting 2025-05-30
Trial Details
NCT Number NCT06473246
Lead Sponsor Vedic Lifesciences Pvt. Ltd.
Conditions Healthy Population
Enrollment 200 participants
Start Date 2025-02-20
Primary Completion 2026-01-05 (estimated)
Study Completion 2026-02-05 (estimated)
Updated on ClinicalTrials.gov 2025-12-30