- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962337
Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis Subjects
December 9, 2021 updated by: Five Prime Therapeutics, Inc.
A Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects With Rheumatoid Arthritis
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Budapest, Hungary
- BIK-Betegápoló Irgalmas rend-Budai Irgalmasrendi Kórház/Polyclinic of the Hospitaller Brothers of St. John of God in Budapest
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Budapest, Hungary
- PRA Clinical Unit
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Kaposvar, Hungary
- Drug Research Center
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Groningen, Netherlands
- PRA Early Development Services
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Krakow, Poland
- Oddział Kliniczny Kliniki Chorób Wewnętrznych Szpitala Uniwersyteckiego w Krakowie
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Poznan, Poland
- MedPolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1-FPA008/Placebo Randomize DoseLevels1-4
Single infusion at 4 different dose levels
|
Infusion
Infusion
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Experimental: 2-FPA008/Placebo Randomize DoseLevels1-2
Dual Infusions at 2 different dose levels
|
Infusion
Infusion
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Experimental: 3-FPA008 Open-Label DoseLevels 1-3
Dual infusions at 1 dose level AND Dual/Triple infusions at 2 different dose levels
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Infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events and dose-limiting toxicities of FPA008 administered in healthy volunteers and RA subjects
Time Frame: within 4-12 weeks
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Incidence of all-grade adverse events and dose limiting toxicities (DLT) during the DLT observation period and/or study treatment periods
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within 4-12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Lead, Five Prime Therapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
October 10, 2013
First Submitted That Met QC Criteria
October 10, 2013
First Posted (Estimate)
October 14, 2013
Study Record Updates
Last Update Posted (Actual)
December 13, 2021
Last Update Submitted That Met QC Criteria
December 9, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPA008-001
- 2013-003337-15 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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