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

September 11, 2023 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M9L 3A2
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3P 3P1
        • Pfizer Investigational Site
  • United States
    • Florida
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
  • Must meet criteria for rheumatoid arthritis with functional class I to III.
  • Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age

Exclusion Criteria:

  • Any significant health problems other than rheumatoid arthritis.
  • Treatment of greater than 10 mg of prednisone per day.
  • Treatment with cyclophosphamide.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
SBI-087
Drug: SBI-087
Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis.
Time Frame: 12 months
12 months

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.

General Publications

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 (Actual)

March 31, 2008

Primary Completion (Actual)

March 31, 2011

Study Completion (Actual)

March 31, 2011

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimated)

March 24, 2008

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3227K1-1000
  • B2261001

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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