NCT03686930

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

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 Administered Orally to Normal, Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Foresee Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Phase I, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD), study to evaluate the safety/tolerability and pharmacokinetics (PK) of FP-045 administered to normal health volunteers (NHVs). 3 cohorts of NHVs will be enrolled. Subjects in each cohort will be randomized to orally receive either FP-045 (6 subjects) or placebo (2 subjects). Subjects will receive 7 daily doses of study drug. Subjects will be screened for study eligibility within 21 days before Day 1 and will have been admitted to the CRU on Day -1 to confirm eligibility and to undergo baseline assessments. Subjects will remain in the CRU for observation until completion of all assessments on Day 10. Subjects will return to the CRU on Day 11 for an additional PK sample, and again for an end of study (EOS) Visit on Day 14 (±2 days) for safety evaluations and collection of PK samples.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-22
• Primary completion: 2018-05-27
• Completion: 2018-08-10
• First posted: 2018-09-27
• Last updated: 2022-04-29

Locations

1 site across 1 country: Australia