MedTrace Logo

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

NCT02238834 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-08-08

No results posted yet for this study

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).

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

Sponsors & Collaborators

  • QPS-Qualitix

    collaborator INDUSTRY

  • Foresee Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02238834 on ClinicalTrials.gov