A study looking at the safety, tolerability absorption, breakdown, and elimination of SCH 900117 from the body in Healthy Volunteers and patients with Rheumatoid Arthritis.

A Rising-Single-Dose and Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of SCH 900117 in Healthy Volunteers and in Subjects with Rheumatoid Arthritis

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000555358

Enrollment

Registered

2008-11-06

Start date

2008-11-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Experiments in animals and research data in humans strongly suggests that IL-17A is involved in the formation of joint inflammation in rheumatoid arthritis. The primary purpose of this study is to establish the safety of blocking the effects of IL-17A with SCH 900117 in healthy subjects and in patients with rheumatoid arthritis.

Interventions

Part 1(Healthy Subjects Only): SCH 900117 12mg, 40mg, 120mg or 400mg. Single dose via subcutaneous injection on Day 1 (Subjects receive only 1 of the 4 possible rising dose levels or placebo. Subjects are randomised to receive active vs placebo). Part 2 (Rheumatoid Arthritis Patients Only): SCH 900117 400mg. Three subcutaneous doses of study drug or placebo over 3 months (Week 0, Week 4, Week 8). Subjects are randomised to receive either active or placebo.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Part 1-Healthy volunteers Part 2-Rheumatoid Arthritis >6mths - >=5 swollen & tender joints

Exclusion criteria

History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C.

Outcome results