NCT02238834

Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers

A Randomized, Double-blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of FP-025, an MMP-12 Inhibitor, in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Foresee Pharmaceuticals Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, placebo controlled, single and multiple ascending dose study to assess the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects. Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).

Detailed description

In the SAD part of the study the investigational drug will be administered once in a dose escalation manner starting from 200 mg in Cohort 1 to 2000 mg in Cohort 6. The study drug will be orally taken as capsules. In the MAD part of the study the investigational drug will be administrated twice daily for 5 days depending on the half-life of FP-025, as determined in the SAD part of the study. Study subjects will be randomized in a 1:3 ratio to either placebo or FP-025 in every cohort of the SAD and MAD part of the study. Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FP-025	Subjects will receive single doses of 200 to up to 800 mg of FP-025 (API-in-capsule) in a dose escalation format (cohorts 1-3). Subjects will receive single doses of 50 to up to 450 mg of FP-025 (ASD-in-capsule) in a dose escalation format (cohorts 4-8).
DRUG	Placebo	Subjects will receive single doses of FP-025 matching placebo (capsule) in a dose escalation format.
DRUG	FP-025	Subjects will receive doses of FP-025 (capsule) twice daily for 5 days.
DRUG	Placebo	Subjects will receive FP-025 matching placebo (capsule) twice daily for 5 days

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2014-09-12
• Last updated: 2022-08-08

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study