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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Five Prime Therapeutics, Inc.

Criteria

Inclusion Criteria:

Part 1 and 2:

• Healthy adult male and female subjects between the ages of 21-55 years inclusive.

• Subject must be willing to remain in the Clinical Research Unit (CRU) for a minimum of 72 hours after each dose.

Part 3:

• RA male and female subjects between the ages of 21-70 years inclusive

• Evidence of active RA disease

• Inadequate response to biologic or non-biologic DMARDs

• Subjects will be required to be on background therapy with methotrexate.

Exclusion Criteria:

Parts 1, 2 and 3:

• BMI <18 or >32 kg/m2

• Clinically significant findings in physical exams and laboratory tests at screening and/or baseline

• Unwilling to abstain from alcohol for 48 hours prior to study start, during CRU confinement, as applicable, and for 48 hours prior to study visits.

• Unwilling to abstain from exercise more strenuous than walking during CRU confinement, as applicable, and for 48 hours prior to study visits.

Parts 1 and 2:

• Use of any prescription, non-prescription, or herbal medications as well as supplements or vitamins within 4 weeks prior to dosing, unless approved by the Investigator.

• Smoking more than 10 cigarettes, or the equivalent, per day.

Part 3:

• Current or previous history of inflammatory joint disease other than RA

• Evidence of extra-articular RA disease or systemic involvement

• Currently taking any medications other than those allowed per protocol guidelines

• Any surgical procedure including bone or joint surgery within 12 weeks prior to dosing

• Use of intra-articular (IA), intramuscular (IM), or IV corticosteroids for RA

• Neuropathies and neurovasculopathies

• Concomitant use of statins while on study.