A Phase 1, Single-Center, Open-label Study to Evaluate the Pharmacokinetics of PRN1008 in Healthy Male and Female Volunteers

Exclusion Criteria11

• Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
• History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
• History of any significant (as determined by the Investigator) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticaria or multiple drug allergies.
• Blood donation or significant blood loss within 30 days prior to screening.
• Plasma donation within 14 days prior to the first study drug administration.
• Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days prior to the first study drug administration or 5 half-lives, whichever is longer.
• Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant.
• Personal or family history of prolonged QT syndrome or family history of sudden death.
• QTcF greater than 450 msec (males) or greater than 470 msec (females) or less than 300 msec at screening or baseline visit, unless deemed clinically insignificant by the Investigator.
• Seated resting systolic blood pressure (SBP) greater than 150 or less than 90 mm Hg, or diastolic blood pressure greater than 95 or less than 50 mm Hg.
• History or presence of any other medical condition that makes the participant unsuitable for the study in the opinion of the Investigator.