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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641225

Enrollment

Registered

2008-03-24

Start date

2008-03-31

Completion date

2011-03-31

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Ascending Single Dose, Safety, Pharmacokinetics, Open-label

Brief summary

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

Interventions

DRUGSBI-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026