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

Completed

• Conditions: rheuma; rheumatoid arthritis; 10003816

• Registration Number: NL-OMON40412
• Lead Sponsor: Five Prime Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

part 1 and 2:
- Healthy adult male and female subjects
- Ages 21*55 years inclusive
- BMI 18-32 kg/m2 inclusive;part 3:
n/a for The Netherlands, will be executed in Eastern Europe

Exclusion Criteria

Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder, that in the opinion of the investigator would place the subject at undue risk.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess safety and tolerability of single and multiple doses of FPA008 in<br /><br>healthy volunteers and in rheumatoid arthritis subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To characterize the pharmacokinetic profile of FPA008 when administered as a<br /><br>single dose (Part 1 only) or a multi-dose regimen (Parts 2 and 3).<br /><br>* To assess pharmacodynamic responses to FPA008 administration in healthy<br /><br>volunteer subjects and rheumatoid arthritis subjects.</p><br>