HealthyPhase 1NCT01962337
Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis Subjects
A Phase 1 study testing FPA008 in people with Healthy and Rheumatoid Arthritis, run by Five Prime Therapeutics, Inc. at 6 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Rheumatoid Arthritis
- What is being tested?
- FPA008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Oct 2013to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 16Show fewer
- 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 locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Hungary3 sites
BIK-Betegápoló Irgalmas rend-Budai Irgalmasrendi Kórház/Polyclinic of the Hospitaller Brothers of St. John of God in Budapest
Budapest
PRA Clinical Unit
Budapest
Drug Research Center
Kaposvár
Poland2 sites
Oddział Kliniczny Kliniki Chorób Wewnętrznych Szpitala Uniwersyteckiego w Krakowie
Krakow
MedPolina
Poznan
About this study
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
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).
Read the 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.
- Conditions
- Healthy, Rheumatoid Arthritis
- Being tested
- FPA008, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPA008Drug
Infusion
PlaceboDrug
Infusion
| Study group | Role | What they receive |
|---|---|---|
| 1-FPA008/Placebo Randomize DoseLevels1-4 | Experimental | Single infusion at 4 different dose levels Receives: Drug: FPA008; Drug: Placebo |
| 2-FPA008/Placebo Randomize DoseLevels1-2 | Experimental | Dual Infusions at 2 different dose levels Receives: Drug: FPA008; Drug: Placebo |
| 3-FPA008 Open-Label DoseLevels 1-3 | Experimental | Dual infusions at 1 dose level AND Dual/Triple infusions at 2 different dose levels Receives: Drug: FPA008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and dose-limiting toxicities of FPA008 administered in healthy volunteers and RA subjects
Incidence of all-grade adverse events and dose limiting toxicities (DLT) during the DLT observation period and/or study treatment periods
Measured: within 4-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: We have discontinued development of FPA008 in RA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Five Prime Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Lead, Study director, Five Prime Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962337
- Sponsor's protocol ID
- FPA008-001
- Other IDs
- 2013-003337-15
- Status last verified
- Dec 2021
- First submitted
- 10 Oct 2013
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01962337
- Acronym / sponsor ID
- FPA008-001
- Conditions
- Healthy, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We have discontinued development of FPA008 in RA
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Five Prime Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-FPA008/Placebo Randomize DoseLevels1-4 | Experimental | Drug: FPA008, Drug: PlaceboSingle infusion at 4 different dose levels |
| 2-FPA008/Placebo Randomize DoseLevels1-2 | Experimental | Drug: FPA008, Drug: PlaceboDual Infusions at 2 different dose levels |
| 3-FPA008 Open-Label DoseLevels 1-3 | Experimental | Drug: FPA008Dual infusions at 1 dose level AND Dual/Triple infusions at 2 different dose levels |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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
Key exclusion criteria (16 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FPA008Infusion | Drug | 1-FPA008/Placebo Randomize DoseLevels1-4, 2-FPA008/Placebo Randomize DoseLevels1-2, 3-FPA008 Open-Label DoseLevels 1-3 |
| PlaceboInfusion | Drug | 1-FPA008/Placebo Randomize DoseLevels1-4, 2-FPA008/Placebo Randomize DoseLevels1-2 |
Primary outcome
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
Results and safety
The study was stopped early (reason given: We have discontinued development of FPA008 in RA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Lead study director
Five Prime Therapeutics
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FPA008 in people with Healthy and Rheumatoid Arthritis, run by Five Prime Therapeutics, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Hungary, Poland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We have discontinued development of FPA008 in RA). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and dose-limiting toxicities of FPA008 administered in healthy volunteers and RA subjects (time frame: within 4-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.