Different doses of VL-SE-01 (CBD formulations) for healthy adults with elevated stress

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.

This trial will test several doses of VL-SE-01 (CBD isolate and broad-extract formulations) versus placebo in healthy adults with stressed lifestyles to see how safe they are and how the body absorbs and clears them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Vedic Lifesciences Pvt. Ltd. (Industry-sponsored)
• Locations: 6 sites (Dombivali, Maharashtra and 5 other locations)
• Trial ID: NCT06473246 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled, parallel trial will enroll about 200 healthy adults and randomize them 1:1:1:1:1 across five arms (CBD isolate 25 mg, 40 mg, 50 mg; CBD broad extract 50 mg; placebo). Participants must be 18–55 years old, have BMI 18.5–29.9, and report elevated perceived stress (PSS 27–40). The study lasts 180 days per participant and is designed to collect safety data, pharmacokinetic profiles, and preliminary efficacy signals related to stress. Approximately 250 will be screened to achieve ~200 randomized and an expected 150 completers after anticipated dropouts.

Who should consider this trial

Good fit: Healthy adults aged 18–55 with BMI 18.5–29.9 who report elevated stress (PSS 27–40), are not pregnant or breastfeeding, and agree to required contraception are the intended participants.

Not a fit: People with significant medical conditions, those outside the specified age or BMI ranges, pregnant or breastfeeding women, or individuals without elevated perceived stress are unlikely to qualify or derive benefit from this study.

Why it matters

Potential benefit: If successful, the results could identify safe, tolerable doses of VL-SE-01 and provide dosing and pharmacokinetic information to guide future development for stress-related uses.

How similar studies have performed: CBD formulations have established safety and pharmacokinetic data in other studies, but this specific VL-SE-01 formulation and dose-comparison design is novel and not previously proven.

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.
* 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:

  1. Not a woman of childbearing potential (WOCBP)
  2. OR agrees to use the contraceptive during the intervention period and for at least 90 days after the last dose of study intervention

Exclusion Criteria:

* 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:

  1. For men, consuming more than 4 drinks on any day or more than 14 drinks/week
  2. 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.

Where this trial is running

Dombivali, Maharashtra and 5 other locations

• Shivam Hospital — Dombivali, Maharashtra, India (Recruiting)
• Dhanwantri Hospital — Pune, Maharashtra, India (Recruiting)
• Vedant Multispeciality Hospital — Pune, Maharashtra, India (Recruiting)
• Punawale Hospital — Pune, Maharashtra, India (Recruiting)
• Vishwaraj Hospital — Pune, Maharashtra, India (Recruiting)
• Shree Ashirwad Hospital — Thane, Maharashtra, India (Recruiting)

Study contacts

• Study coordinator: Dr Sanjay Vaze, MBBS

Conditions Healthy Population