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

NCT ID: NCT01962337

Last Updated: 2021-12-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-04-30

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.

Conditions

Healthy; Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1-FPA008/Placebo Randomize DoseLevels1-4

Single infusion at 4 different dose levels

Group Type: EXPERIMENTAL

FPA008

Intervention Type: DRUG

Infusion

Placebo

Intervention Type: DRUG

Infusion

2-FPA008/Placebo Randomize DoseLevels1-2

Dual Infusions at 2 different dose levels

Group Type: EXPERIMENTAL

FPA008

Intervention Type: DRUG

Infusion

Placebo

Intervention Type: DRUG

Infusion

3-FPA008 Open-Label DoseLevels 1-3

Dual infusions at 1 dose level AND Dual/Triple infusions at 2 different dose levels

Group Type: EXPERIMENTAL

FPA008

Intervention Type: DRUG

Infusion

Interventions

FPA008

Infusion

Intervention Type: DRUG

Placebo

Infusion

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Five Prime Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Lead

Role: STUDY_DIRECTOR

Five Prime Therapeutics

Locations

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

Kaposvár, , Hungary

PRA Early Development Services

Groningen, , Netherlands

Oddział Kliniczny Kliniki Chorób Wewnętrznych Szpitala Uniwersyteckiego w Krakowie

Krakow, , Poland

MedPolina

Poznan, , Poland

Countries

Hungary; Netherlands; Poland

Other Identifiers

2013-003337-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FPA008-001

Identifier Type: -

Identifier Source: org_study_id