A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered PRN2246 in Healthy Volunteers

Placebo-controlled, First-In-Human study assessing the safety, tolerability, and pharmacokinetics of PRN2246. Part A Up to 48 participants in 5 cohorts will take part in Part A of the study. Participants in Part A will receive a single dose of PRN2246 liquid formulation. Planned doses in Part A are Cohort A1 7.5mg, Cohort A2 15mg, Cohort A3 30mg, Cohort A4 60mg, and Cohort A5 120mg.. Participants in Part A will receive the liquid formulation whilst fasting with the exception of 1 cross over cohort that will receive the liquid formulation administered with and without food (with up to a 7 day washout between doses). Part B Up to 50 participants in up to 5 cohorts will take part in Part B of the study. Participants in Part B of the study will receive one dose of PRN2246 liquid formulation per day for 10 days (doses to be assigned based on data from Part A). Planned doses in Part B are Cohort B1 7.5mg, Cohort B2 15mg, Cohort B3 30mg, Cohort B4 60mg, Cohort B5 120mg. Part C Up to 8 participants (two groups of 4 participants each) will take part in Part C of the study. Part C will be open label and participants will receive one single 120mg dose of PRN2246 liquid formulation. Dose escalation to subsequent cohorts in Part A and B will occur following review of the safety, tolerability, and available PK/PD information from the previous dose level. Dose levels may be adjusted based on emerging safety, tolerability, and PK data. Study subjects will be domiciled during the study and adherence to the dosing regimen will be monitored by study staff observations, notes. Accurate dose and accountability will be checked before and after dosing.