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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01962337
Recruitment Status : Terminated (We have discontinued development of FPA008 in RA)
First Posted : October 14, 2013
Last Update Posted : December 13, 2021
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Healthy Rheumatoid Arthritis Drug: FPA008 Drug: Placebo Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1-FPA008/Placebo Randomize DoseLevels1-4
Single infusion at 4 different dose levels
Drug: FPA008

Drug: Placebo

Experimental: 2-FPA008/Placebo Randomize DoseLevels1-2
Dual Infusions at 2 different dose levels
Drug: FPA008

Drug: Placebo

Experimental: 3-FPA008 Open-Label DoseLevels 1-3
Dual infusions at 1 dose level AND Dual/Triple infusions at 2 different dose levels
Drug: FPA008

Primary Outcome Measures :
  1. Incidence of adverse events and dose-limiting toxicities of FPA008 administered in healthy volunteers and RA subjects [ Time Frame: within 4-12 weeks ]
    Incidence of all-grade adverse events and dose limiting toxicities (DLT) during the DLT observation period and/or study treatment periods

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962337

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BIK-Betegápoló Irgalmas rend-Budai Irgalmasrendi Kórház/Polyclinic of the Hospitaller Brothers of St. John of God in Budapest
Budapest, Hungary
PRA Clinical Unit
Budapest, Hungary
Drug Research Center
Kaposvar, Hungary
PRA Early Development Services
Groningen, Netherlands
Oddział Kliniczny Kliniki Chorób Wewnętrznych Szpitala Uniwersyteckiego w Krakowie
Krakow, Poland
Poznan, Poland
Sponsors and Collaborators
Five Prime Therapeutics, Inc.
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Study Director: Medical Lead Five Prime Therapeutics
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Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01962337    
Other Study ID Numbers: FPA008-001
2013-003337-15 ( EudraCT Number )
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: December 13, 2021
Last Verified: December 2021
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases