A Single-Dose Safety and Tolerability Placebo Controlled Study of Subcutaneous SCH 900222 in Healthy Volunteers

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2009
INTERVENTION: A single dose of either 50mg or 200mg SCH 900222 administered as a subcutaneous single injection. CONDITION: The use of SCH 900222 for autoimmune disorders. PRIMARY OUTCOME: To determine the safety and tolerability of a rising single subcutaneous fixed dose of SCH 900222 in healthy subjects. ; (Assessed via vital sign measurements, standard laboratory safety tests, urinalysis &/or physical examinations) SECONDARY OUTCOME: 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) INCLUSION CRITERIA: ‐Male/Female Healthy volunteers must have no history of latent or active tuberculosis (TB) prior to screening
Epistemonikos ID: 0679182b9b44cb8aad51daf889150101534195a2
First added on: Aug 25, 2024