A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of IPI-201 Administered Intravenously in Healthy Male Participants

Exclusion Criteria23

• Any clinically significant abnormal finding at physical examination.
• eGFR not to be less than 80mL/min/1.73m2
• Significant past history of depression or suicidality, or depressive disorder in previous 12 months.
• Positive C-SSRS on lifetime ideation or behaviour.
• Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen, hepatitis C virus antibody (HCV Ab) (unless HCV RNA negative), or HIV antigen or antibody at screening. Positive HCV Ab with negative HCV RNA would be acceptable for eligibility.
• Positive urine drug screen (including tetrahydrocannabinol), urine cotinine test, or alcohol breath test.
• History of significant allergic reactions (e.g., anaphylactic reaction, hypersensitivity, angioedema) to CBD or any drug or any adverse reaction to CBD.
• Clinically significant ECG abnormalities, or QTcF more than 450 msec at screening.
• Vital signs abnormalities at screening, D-1 or pre-dose, which remain similar upon repeat:
• Systolic blood pressure less than 90 or more than 140 mmHg
• Diastolic blood pressure less than 40 or more than 90 mmHg
• Heart rate less than 40 or more than 100 bpm
• History of drug abuse within 1 year prior to screening.
• Unwilling to abstain from consuming alcohol from 24 hours prior to check-in on Day -1, whilst confined at the clinic, and until after the last PK sample on Day 4.
• History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening defined as consuming more than 21 standard drinks per week for males, where 1 standard drink equals 375ml of mid-strength beer (3.5% alcohol/volume), 100ml wine (13.5% alcohol/volume) or 30ml of spirits (40% alcohol/volume).
• Any of the following laboratory parameters 1.5x above the upper limit of normal (ULN) values at screening or baseline (Day -1): aspartate aminotransferase, alanine aminotransferase, direct bilirubin, indirect bilirubin, and total bilirubin.
• History of liver disease or hepatic dysfunction (including cirrhosis), and jaundice.
• History of epilepsy.
• Use of concomitant medications listed in the study protocol.
• Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30?days prior to dosing, administration of a biological product in the context of a clinical research study within 90?days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
• Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
• Participant who is not willing or able to comply with study requirement (e.g., presents difficulty with venipuncture and/or has poor venous access).
• Any reason which, in the opinion of the Investigator or delegate, would prevent the participant from participating in the study.