A Single-Dose Safety and Tolerability Placebo Controlled Study of Subcutaneous SCH 900222 in Healthy Volunteers
Recruiting
- Conditions
- The use of SCH 900222 for autoimmune disorders.Inflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12609000233224
- Lead Sponsor
- Schering-Plough
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Male/Female Healthy volunteers must have no history of latent or active tuberculosis (TB) prior to screening
Exclusion Criteria
History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, active or latent mycobacterium tuberculosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the safety and tolerability of a rising single subcutaneous fixed dose of SCH 900222 in healthy subjects.<br>(Assessed via vital sign measurements, standard laboratory safety tests, urinalysis &/or physical examinations)[Assessed throughout the study at each study visit between Days 1-140 (13 visits).]
- Secondary Outcome Measures
Name Time Method To determine the relative bioavailability and pharmacokinetics of rising subcutaneous dose of SCH 900222 compared to parallel intravenous dosing in healthy subjects. (Assessed via pharmacokinetic (PK) blood sample analysis)[Assessed throughout the study at each study visit between Days 1-140 (13 visits).]