A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.
Recruiting
N/A
Interventional Study
Healthy Population
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 200 (estimated)
- Sponsor
- Vedic Lifesciences Pvt. Ltd. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 complet…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* Male \& female individuals must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Individuals who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Indiv…
Contacts