Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis

August 12, 2024 updated by: Pfizer

An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis

The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Ehime, Japan
        • Pfizer Investigational Site
      • Fukui, Japan
        • Pfizer Investigational Site
      • Kanagawa, Japan
        • Pfizer Investigational Site
      • Miyagi, Japan
        • Pfizer Investigational Site
      • Oita, Japan
        • Pfizer Investigational Site
      • Shizuoka, Japan
        • Pfizer Investigational Site
      • Tokyo, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must meet American College of Rheumatology criteria for rheumatoid arthritis with functional class I to III.
  • Rheumatoid arthritis disease onset at >16 years of age and duration of disease at least 6 months.
  • Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at the screening visit.

Exclusion Criteria:

  • Any significant health problems other than rheumatoid arthritis.
  • Treatment of greater than 10 mg of prednisone per day.
  • Therapy with immunosuppressants within 6 months before study day 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBI-087 0.15 mg IV
Drug: SBI-087
IV, Single dose
Drug: SBI-087
SC, Single dose
Experimental: SBI-087 0.5 mg IV
Drug: SBI-087
IV, Single dose
Drug: SBI-087
SC, Single dose
Experimental: SBI-087 100 mg SC
Drug: SBI-087
IV, Single dose
Drug: SBI-087
SC, Single dose
Experimental: SBI-087 200 mg SC
Drug: SBI-087
IV, Single dose
Drug: SBI-087
SC, Single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA
Time Frame: 12 months
12 months
To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087
Time Frame: 12 month
12 month
To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Emergent Product Development Seattle LLC

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 30, 2008

First Posted (Estimated)

December 31, 2008

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3227K1-1001
  • B2261002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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