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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01962337
• Other study ID #: FPA008-001
• Secondary ID: 2013-003337-15
• Status: Terminated
• Phase: Phase 1
• Start date: October 2013
• Est. completion date: April 2016

Study information

• Verified date: December 2021
• Source: Five Prime Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Healthy
• Rheumatoid Arthritis

Intervention

Drug:
• FPA008
Infusion
• Placebo
Infusion

Locations

Country	Name	City	State
Hungary	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	Kaposvar
Netherlands	PRA Early Development Services	Groningen
Poland	Oddzial Kliniczny Kliniki Chorób Wewnetrznych Szpitala Uniwersyteckiego w Krakowie	Krakow
Poland	MedPolina	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Five Prime Therapeutics, Inc.

Countries where clinical trial is conducted

Hungary,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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