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

Five Prime Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Healthy; Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: FPA008

Study type: Interventional

Funder types: Industry

Identifiers

NCT01962337

FPA008-001

2013-003337-15 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 3 patient groups

1-FPA008/Placebo Randomize DoseLevels1-4

Experimental group

Description:

Single infusion at 4 different dose levels

Treatment:

Drug: FPA008

Drug: Placebo

2-FPA008/Placebo Randomize DoseLevels1-2

Experimental group

Description:

Dual Infusions at 2 different dose levels

Treatment:

Drug: FPA008

Drug: Placebo

3-FPA008 Open-Label DoseLevels 1-3

Experimental group

Description:

Dual infusions at 1 dose level AND Dual/Triple infusions at 2 different dose levels

Treatment:

Drug: FPA008