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

NCT01962337 | Terminated Phase 1

• 2 other identifiers: FPA008-0012013-003337-15
• Study Type: interventional
• Target: 66
• Locations: 3 countries
• Sites: 6

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).

Conditions

Healthy; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

  within 4-12 weeks

Study Arms (3)

1-FPA008/Placebo Randomize DoseLevels1-4

EXPERIMENTAL

Single infusion at 4 different dose levels

Drug: FPA008; Drug: Placebo

2-FPA008/Placebo Randomize DoseLevels1-2

EXPERIMENTAL

Dual Infusions at 2 different dose levels

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

Drug: FPA008

Interventions

FPA008 DRUG

Infusion

1-FPA008/Placebo Randomize DoseLevels1-4; 2-FPA008/Placebo Randomize DoseLevels1-2; 3-FPA008 Open-Label DoseLevels 1-3

Placebo DRUG

Infusion

1-FPA008/Placebo Randomize DoseLevels1-4; 2-FPA008/Placebo Randomize DoseLevels1-2

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Five Prime Therapeutics, Inc.: lead

Study Sites (6)

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

Budapest, Hungary

Location

PRA Clinical Unit

Budapest, Hungary

Location

Drug Research Center

Kaposvár, Hungary

Location

PRA Early Development Services

Groningen, Netherlands

Location

Oddział Kliniczny Kliniki Chorób Wewnętrznych Szpitala Uniwersyteckiego w Krakowie

Krakow, Poland

Location

MedPolina

Poznan, Poland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Lead

  Five Prime Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 14, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

HU (3); NL (1); PL (2)