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

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Healthy
Interventions
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

Trial Locations (1)

11217

Taipei Veterans General Hospital, Taipei

All Listed Sponsors
collaborator

QPS-Qualitix

INDUSTRY

lead

Foresee Pharmaceuticals Co., Ltd.

INDUSTRY

NCT02238834 - Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers | Biotech Hunter | Biotech Hunter