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A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.
Led by Vedic Lifesciences Pvt. Ltd. · Updated on 2025-12-30
200
Participants Needed
6
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female individuals aged 18 to 55 years at consent
- Healthy as determined by medical evaluation including history, physical exam, labs, and cardiac monitoring
- Body weight of at least 50 kg for males or 45 kg for females
- Body mass index (BMI) between 18.5 and 29.9 kg/m2 inclusive
- Stressed lifestyle with Perceived Stress Scale (PSS) scores between 27 and 40
- Males agree to use contraception during treatment and 7 days after last dose and avoid sperm donation
- Females must not be pregnant or breastfeeding and either not of childbearing potential or agree to contraception during treatment and 90 days after last dose
You will not qualify if you...
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that affect drug metabolism or pose risk
- Males with history of oligospermia, vasectomy, or sperm abnormalities
- Females with menstrual irregularities or polycystic ovarian syndrome
- Individuals with Type 1 or Type 2 diabetes on medication
- Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
- Individuals on antihypertensive medications
- History or current chronic alcohol use exceeding defined limits (men: >4 drinks/day or >14/week; women: >3 drinks/day or >7/week)
- Peri- or post-menopausal women with no menstrual cycle in past 6 months
- History or current use of hemp or CBD products
- Known hypersensitivity to study medication components
- History of unexplained fainting or family history of sudden death from long QT syndrome
- History or diagnosis of cancer such as lymphoma, leukemia, or malignancy
- Use of prohibited or prescription medications including herbal meds within 2 weeks or 5 half-lives prior to dosing
- Use of sleep medication within 2 weeks prior to screening
- Use of hepatic enzyme-inducing drugs within 2 months prior to dosing
- Elevated liver enzymes (ALT, AST, ALP) >1.5 times upper limit of normal
- Current or chronic liver disease or known hepatic/biliary abnormalities except Gilbert's syndrome or asymptomatic gallstones
- Clinically relevant ECG findings at screening or baseline
- History of HIV, hepatitis B, or hepatitis C infection
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Shivam Hospital
Dombivali, Maharashtra, India, 421203
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2
Dhanwantri Hospital
Pune, Maharashtra, India, 411011
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3
Vedant Multispeciality Hospital
Pune, Maharashtra, India, 411019
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4
Punawale Hospital
Pune, Maharashtra, India, 411033
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5
Vishwaraj Hospital
Pune, Maharashtra, India, 412201
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6
Shree Ashirwad Hospital
Thane, Maharashtra, India, 421201
Actively Recruiting
Research Team
D
Dr Sanjay Vaze, MBBS
CONTACT
D
Dr. Lalit Pawaskar, M.Pharm, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
5
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