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

Официальное название

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.

Обзор

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.

Вмешательства

• Пищевая добавка CBD Isolate (25 mg/0.5 ml)
  0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
• Пищевая добавка CBD Isolate (40 mg/0.5 ml)
  0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
• Пищевая добавка CBD Isolate (50 mg/0.5 ml)
  0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
• Пищевая добавка 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.
• Пищевая добавка Placebo
  0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Первичные конечные точки

• 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. [Срок оценки: Day -5 to Day -1]
• 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. [Срок оценки: Day 90]
• 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. [Срок оценки: Day 180]
• 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. [Срок оценки: Day -5 to Day -1]
• 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. [Срок оценки: Day 90]
• 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. [Срок оценки: Day 180]
• 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. [Срок оценки: Day -5 to -1]
• 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. [Срок оценки: Day 90]
• 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. [Срок оценки: Day 180]

Вторичные конечные точки (12)

• To assess the safety and tolerability of VL-SE-01 using blood, which includes Complete Blood Count (CBC). [Срок оценки: Day -5 to Day -1, Day 90, Day 180 and Day 195]
• To assess the safety and tolerability of VL-SE-01 using blood, which includes Inflammation by analyzing CRP levels. [Срок оценки: Day 0, Day 90, Day 180 and Day 195]
• To assess the safety and tolerability of VL-SE-01 using blood, which includes Hormonal profile (Luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone, estradiol and progesterone) [Срок оценки: Day 0, Day 90, Day 180 and Day 195]
• To assess the safety and tolerability of VL-SE-01 using blood, which includes Thyroid profile (T3, T4, TSH) [Срок оценки: Day 0, Day 90, Day 180 and Day 195]
• To assess the safety and tolerability of VL-SE-01 using blood, which includes Lipid Profile as assessed by levels of total cholesterol, LDL, HDL and triglycerides [Срок оценки: Day 0, Day 90, Day 180 and Day 195]
• To assess the safety and tolerability of VL-SE-01 on Semen. [Срок оценки: Day -5 to Day -1 and Day 180]
• To assess the safety and tolerability of VL-SE-01 using blood Plasma levels of CBD and its metabolites [7-Carboxy-cannabidiol (7-COOH-CBD) and 7-Hydroxy-cannabidiol (7-OH-CBD)] [Срок оценки: Day 195 (single timepoint)]
• To assess the safety and tolerability of VL-SE-01 on Blood Pressure. [Срок оценки: Day 0, Day 90, Day 180 and Day 195]
• To assess the safety and tolerability of VL-SE-01 on Pulse Rate. [Срок оценки: Day 0, Day 90, Day 180 and Day 195]
• To assess the safety and tolerability of VL-SE-01 using Electrocardiogram. [Срок оценки: Day 0, Day 90, Day 180 and Day 195]
• To assess the safety and tolerability of VL-SE-01 using Treatment emergent Adverse Events (TEAEs). [Срок оценки: Day 0, Day 90, Day 180 and Day 195]
• To evaluate the efficacy of VL-SE-01 on the basis of Incidence of gastrointestinal dysfunction using Structured Assessment of Gastrointestinal Symptoms (SAGIS) questionnaire. [Срок оценки: Day 0, Day 90, and Day 180]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Индия · 6 центров

• Shivam Hospital — Dombivali
• Dhanwantri Hospital — Pune
• Vedant Multispeciality Hospital — Pune
• Punawale Hospital — Pune
• Vishwaraj Hospital — Pune
• Shree Ashirwad Hospital — Thane

Идентификаторы

NCT: NCT06473246 · SE/230302/CBD/SS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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