A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.
A Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.
Vedic Lifesciences Pvt. Ltd.
200 participants
Feb 20, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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.
- Individual has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18.5 to 29.9 kg/m2 (inclusive)
- Individuals with a stressed lifestyle as assessed by PSS scores within 27- 40.
- A male must agree to use contraception during the intervention period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period.
- A female is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP)
- OR agrees to use the contraceptive during the intervention period and for at least 90 days after the last dose of study intervention
Exclusion Criteria21
- Individual has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinology related, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention, or interfering with the interpretation of data.
- Males who has a history of oligospermia, vasectomy and other sperm abnormalities.
- Females who have irregularity or problems in menstrual cycles or diagnosed with polycystic ovarian syndrome.
- Individuals with Type 1 and Type 2 Diabetes mellitus and on medication.
- Individuals with SBP ≥ 160 mmHg and DBP ≥ 100 mmHg.
- Individuals on anti-hypertensives.
- History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by:
- For men, consuming more than 4 drinks on any day or more than 14 drinks/week
- For women, consuming more than 3 drinks on any day or more than 7 drinks/week
- Peri and post-menopausal women with no menstrual cycle in the last 6 months
- Individuals with a history or actively under the influence of Hemp or CBD products by any means of administration
- Individual has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol
- Individual has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
- Individual with a history and/or currently diagnosed of cancer like lymphoma, leukaemia, or any malignancy.
- Individual has past or intended use of prohibited medication or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing
- Individuals have taken sleep medication within 2 weeks prior to screening
- Individual has used hepatic enzyme-inducing drugs within 2 months prior to dosing
- Individuals has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \>1.5 times upper limit of normal (ULN)
- Individual has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Individual has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline
- Individual has a history of human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
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Interventions
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06473246