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

Phase 1

Terminated

• Conditions: Healthy; Rheumatoid Arthritis
• Interventions: Drug: FPA008; Drug: Placebo

• Registration Number: NCT01962337
• Lead Sponsor: 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-14
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 66

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-FPA008/Placebo Randomize DoseLevels1-2	FPA008	Dual Infusions at 2 different dose levels
1-FPA008/Placebo Randomize DoseLevels1-4	FPA008	Single infusion at 4 different dose levels
3-FPA008 Open-Label DoseLevels 1-3	FPA008	Dual infusions at 1 dose level AND Dual/Triple infusions at 2 different dose levels
1-FPA008/Placebo Randomize DoseLevels1-4	Placebo	Single infusion at 4 different dose levels
2-FPA008/Placebo Randomize DoseLevels1-2	Placebo	Dual Infusions at 2 different dose levels

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Drug Research Center; 🇭🇺 Kaposvar, Hungary

PRA Clinical Unit; 🇭🇺 Budapest, Hungary

MedPolina; 🇵🇱 Poznan, Poland

Oddział Kliniczny Kliniki Chorób Wewnętrznych Szpitala Uniwersyteckiego w Krakowie; 🇵🇱 Krakow, Poland

BIK-Betegápoló Irgalmas rend-Budai Irgalmasrendi Kórház/Polyclinic of the Hospitaller Brothers of St. John of God in Budapest; 🇭🇺 Budapest, Hungary

PRA Early Development Services; 🇳🇱 Groningen, Netherlands