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

Sponsor
Five Prime Therapeutics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01962337
Collaborator
(none)
66
Enrollment
6
Locations
3
Arms
30
Duration (Months)
11
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Oct 1, 2013
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1-FPA008/Placebo Randomize DoseLevels1-4

Single infusion at 4 different dose levels

Drug: FPA008
Infusion

Drug: Placebo
Infusion
Experimental: 2-FPA008/Placebo Randomize DoseLevels1-2

Dual Infusions at 2 different dose levels

Drug: FPA008
Infusion

Drug: Placebo
Infusion
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
Infusion

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events and dose-limiting toxicities of FPA008 administered in healthy volunteers and RA subjects [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 70 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 BIK-Betegápoló Irgalmas rend-Budai Irgalmasrendi Kórház/Polyclinic of the Hospitaller Brothers of St. John of God in Budapest Budapest Hungary
2 PRA Clinical Unit Budapest Hungary
3 Drug Research Center Kaposvar Hungary
4 PRA Early Development Services Groningen Netherlands
5 Oddział Kliniczny Kliniki Chorób Wewnętrznych Szpitala Uniwersyteckiego w Krakowie Krakow Poland
6 MedPolina Poznan Poland

Sponsors and Collaborators

  • Five Prime Therapeutics, Inc.

Investigators

  • Study Director: Medical Lead, Five Prime Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01962337
Other Study ID Numbers:
  • FPA008-001
  • 2013-003337-15
First Posted:
Oct 14, 2013
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Dec 13, 2021