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

NCT06473246 · tracked via the Priya Life Science India tracker

Sponsor

Vedic Lifesciences Pvt. Ltd.

Phase

Not applicable

Started

2025-02-20

Last updated

2025-12-30

Condition(s) studied

Healthy Population

Investigational drug(s) / intervention(s)

CBD Isolate (25 mg/0.5 ml)CBD Isolate (40 mg/0.5 ml)CBD Isolate (50 mg/0.5 ml)CBD Broad Extract (50 mg/0.5 ml)Placebo

CBD Isolate (25 mg/0.5 ml): 0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

CBD Isolate (40 mg/0.5 ml): 0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

CBD Isolate (50 mg/0.5 ml): 0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

CBD Broad Extract (50 mg/0.5 ml): 0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Placebo: 0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Study 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

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption. — Day -5 to Day -1
Fasting Glucose normal range is 74 - 106 mg/dL
To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption. — Day 90
Fasting Glucose normal range is 74 - 106 mg/dL
To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption. — Day 180
Fasting Glucose normal range is 74 - 106 mg/dL
To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption. — Day -5 to Day -1
Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Glomerular Filtration Rate (GFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL GFR: Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL
To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption. — Day 90
Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Glomerular Filtration Rate (GFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL GFR: Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL
To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption. — Day 180
Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Estimated Glomerular Filtration Rate (eGFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL eGFR: 60 - 200 mL/min/1.73 m² Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL
To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption. — Day -5 to -1
Liver Function tests help determine the health of liver by measuring the levels of Albumin, Total Proteins, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Bilirubin, and gamma-glutamyl transferase (GGT) levels in blood. Albumin: 3.5 - 5.2 g/dL Total Proteins: 6.6 - 8.9 g/dL Alkaline Phosphatase: Males - 40 - 129 U/L; Females - 35 - 104 U/L ALT: Males - Up to 41 U/L; Females - Up to 33 U/L AST: Males - Up to 40 U/L; Females - Up to 32 U/L Bilirubin: Total Bilirubin - Up to 1.2 mg/dL; Direct Bilirubin - Up to 0.3 mg/dL; Indirect Bilirubin - Up to 0.9 mg/dL GGT: Males - 10 - 71 U/L; Females - 6 - 42 U/L
To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption. — Day 90
Liver Function tests help determine the health of liver by measuring the levels of Albumin, Total Proteins, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Bilirubin, and gamma-glutamyl transferase (GGT) levels in blood. Albumin: 3.5 - 5.2 g/dL Total Proteins: 6.6 - 8.9 g/dL Alkaline Phosphatase: Males - 40 - 129 U/L; Females - 35 - 104 U/L ALT: Males - Up to 41 U/L; Females - Up to 33 U/L AST: Males - Up to 40 U/L; Females - Up to 32 U/L Bilirubin: Total Bilirubin - Up to 1.2 mg/dL; Direct Bilirubin - Up to 0.3 mg/dL; Indirect Bilirubin - Up to 0.9 mg/dL GGT: Males - 10 - 71 U/L; Females - 6 - 42 U/L
To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption. — Day 180
Liver Function tests help determine the health of liver by measuring the levels of Albumin, Total Proteins, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Bilirubin, and gamma-glutamyl transferase (GGT) levels in blood. Albumin: 3.5 - 5.2 g/dL Total Proteins: 6.6 - 8.9 g/dL Alkaline Phosphatase: Males - 40 - 129 U/L; Females - 35 - 104 U/L ALT: Males - Up to 41 U/L; Females - Up to 33 U/L AST: Males - Up to 40 U/L; Females - Up to 32 U/L Bilirubin: Total Bilirubin - Up to 1.2 mg/dL; Direct Bilirubin - Up to 0.3 mg/dL; Indirect Bilirubin - Up to 0.9 mg/dL GGT: Males - 10 - 71 U/L; Females - 6 - 42 U/L

Trial sites (6)

Facility	City	Region	Status
Shivam Hospital	Dombivali	Maharashtra	Recruiting
Dhanwantri Hospital	Pune	Maharashtra	Recruiting
Vedant Multispeciality Hospital	Pune	Maharashtra	Recruiting
Punawale Hospital	Pune	Maharashtra	Recruiting
Vishwaraj Hospital	Pune	Maharashtra	Recruiting
Shree Ashirwad Hospital	Thane	Maharashtra	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06473246 on ClinicalTrials.gov ↗ ← All trials in India