NCT01962337

Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis Subjects

A Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects With Rheumatoid Arthritis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Five Prime Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled study designed in 3 parts to assess the safety, tolerability, and PK of single and multiple ascending doses of FPA008 in adult healthy volunteers (Parts 1 and 2) and adult subjects with active RA (Part 3).

Detailed description

Approximately 56 healthy volunteers will be enrolled at 1 study center in the Netherlands for Parts 1 and 2, and approximately 39 subjects will be enrolled at up to 6 sites in Central and Eastern Europe for Part 3. Dose escalations in Parts 1 and 2 will be driven by an assessment of the safety profile. Review of safety and PK parameters may inform decisions to add cohorts with intermediate dose levels in order to reach an optimal target exposure.

Conditions

• Healthy
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	FPA008	Infusion
DRUG	Placebo	Infusion

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-10-14
• Last updated: 2021-12-13

Locations

6 sites across 3 countries: Hungary, Netherlands, Poland