NCT03686930 - Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 | Biotech Hunter

Enrollment

24

Participants

Timeline

Start Date

February 22, 2018

Primary Completion Date

May 27, 2018

Study Completion Date

August 10, 2018

Conditions

Healthy Volunteers

Interventions

DRUG

Cohort 1 - FP-045 oral solution

FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.

DRUG

Cohort 2 - FP-045 oral solution

FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.

DRUG

Cohort 3 - FP-045 oral solution

FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.

DRUG

Placebo (for FP-045 oral solution)

Participants (cohorts 1-3) will receive FP-045 oral solution matching placebo.

Trial Locations (1)

Unknown

Nucleus Networks, Melbourne