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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40412

Enrollment

Registered

2013-09-30

Start date

2013-10-29

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheuma rheumatoid arthritis

Interventions

During part 1 the volunteers will receive a single ascending dose of FPA008, during part 2 a multiple ascending dose. Each group of volunteers will be divided into 2 subgroups. The first 2 volunteer

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To assess safety and tolerability of single and multiple doses of FPA008 in healthy volunteers and in rheumatoid arthritis subjects.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)