None listed
Conditions
Brief summary
This research project is being conducted to investigate the safety, tolerability, and pharmacokinetics of single ascending dose and multiple ascending dose of oral EHP-101 when administered in healthy adult subjects.
Interventions
Part 1 - Single Ascending Dose (SAD)
7 cohorts of healthy volunteers dosed with single doses of oral EHP-101 liquid (7 planned dose levels from 0.91 to 200 mg), or placebo, and additional cohort (8) with one single dose of oral EHP-101 or placebo dosed under fasted and fed condition.
Participants will be confined to the Study Unit from Day -1 and discharged following collection of the 48 hour post dose assessments (Day 3). Total duration of participant involvement in Part 1 is 31 days from Day -
Part 1 - Single Ascending Dose (SAD) 7 cohorts of healthy volunteers dosed with single doses of oral EHP-101 liquid (7 planned dose levels from 0.91 to 200 mg), or placebo, and additional cohort (8) with one single dose of oral EHP-101 or placebo dosed under fasted and fed condition. Participants will be confined to the Study Unit from Day -1 and discharged following collection of the 48 hour post dose assessments (Day 3). Total duration of participant involvement in Part 1 is 31 days from Day -1 admission to Day 30 End of Study assessments, with 4 days of clinic confinement. Part 2 - Multiple Ascending Dose (MAD) 4 cohorts of healthy volunteers dosed with multiple doses (once or twice daily for a period of 7 days) of oral EHP-101 liquid (4 dose levels), or placebo. Participants will be confined to the Study Unit from Day -1 and discharged on Day 9. Total duration of participant involvement in Part 2 is 31 days from Day -1 admission to Day 30 End of Study assessments, with 10 days of clinic confinement. Each dose level investigated in the MAD part will not exceed the tested dose levels in the SAD part for which safety, tolerability, and PK data have been available and reviewed by the safety review committee. Note for both Part 1 (SAD) and Part 2 (MAD): Volunteers were administered treatment under supervision by qualified staff in clinical confinement. Drug administration compliance and accountability was checked by monitors during monitoring visits.
Sponsors
Emerald Health Pharmaceuticals Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female subjects greater than or equal to 18 to less than or equal to 65 years of age. 2. Body mass index (BMI) range 18 to 34 kg/m^2. 3. Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG), echocardiography, ophthalmologic examinations and tests, and laboratory evaluations at screening and admission, as judged by the Investigator. 4. Cardiac Troponin I level below the upper limit of normal, as defined by the manufacturer. 5. Ability to understand and the willingness to provide informed consent for participation in the study. 6. Ability and willingness, as judged by the Investigator, to comply with all study requirements.
Exclusion criteria
1. Any known, documented, or suspected history of: a) schizophrenia or other psychotic illness, or diagnosis of schizophrenia in a first-degree relative. b) alcohol or substance abuse within the last 2 years before screening or positive test result(s) for alcohol and or drugs of abuse. c) Regular alcohol consumption greater than 21 units per week 2. Use of nicotine or nicotine-containing products during participation in the study. 3. Caffeine consumption is limited to no more than 2 units per day. 4. Any known, documented, or suspected hypersensitivity to cannabinoids or any of the excipients of EHP-101 Liquid. 5. Use of cannabis or cannabinoid-based medications. 6. Abnormal screening 12-lead ECG interpreted by the Investigator to be clinically significant. 7. Presence of ophthalmologic abnormalities at baseline, specifically known closed angles, previous laser iridotomy, or severe hypermetropic diagnosis. 8. Male subjects who are not surgically sterilized and who do not agree to use condoms in combination with partner use of a highly effective method of contraception. Female subjects of childbearing potential who are not using a highly effective method of contraception, as judged by the Investigator, and who do not consent: i) to use a combined barrier method of contraception and ii) to remain on a highly effective method of contraception while receiving study intervention during the study and for at least 90 days after the end of study treatment. 9. Female subjects who are pregnant, lactating, or planning pregnancy during the course of the study and for 12 weeks thereafter. 10. Male subjects unwilling to abstain from sperm donation during the study and for 12 weeks thereafter. 11. Any evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV types 1 and 2) infection. 12. Subjects who have received an IP within the 12 weeks before the screening visit. 13. Blood donation or loss (eg, greater than or equal to 400 mL) within 3 months before enrollment and unwilling to abstain from blood donation during the study. 14. Significant disease or disorder, which, in the opinion of the Investigator or other staff who is directly involved in the study, may either put the subject at risk because of participation in the study or interfere with the subject's ability to participate in the study. 15. Intake of any metabolic enzyme-affecting drugs from 30 days prior to Day -1 (ie, Check-in). 16. Vaccination within 30 days prior to enrollment.
Outcome results
None listed