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

NCT01962337 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-12-13

No results posted yet for this study

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

Interventions

DRUG

FPA008

Infusion

DRUG

Placebo

Infusion

Sponsors & Collaborators

  • Five Prime Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Lead · Five Prime Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Hungary
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01962337 on ClinicalTrials.gov