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

Healthy Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01962337
Study type Interventional
Source Five Prime Therapeutics, Inc.
Contact
Status Terminated
Phase Phase 1
Start date October 2013
Completion date April 2016
View Details
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