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関節リウマチ患者におけるサリルマブおよびトシリズマブの安全性を評価するための単回投与試験
基本情報
- NCT ID
- NCT02404558
- ステータス
- 完了
- 試験のフェーズ
- 第1相
- 試験タイプ
- 介入
- 目標被験者数
- 30
- 治験依頼者名
- Sanofi
概要
Primary Objective: To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA). Secondary Objectives: To describe the laboratory abnormalities (absolute neutrophil count \[ANC\], platelet counts, total cholesterol, high-density lipoprotein \[HDL\] cholesterol, low-density lipoprotein \[LDL\] cholesterol, and liver function tests \[LFTs\]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA. To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.
対象疾患
Rheumatoid Arthritis
介入
sarilumab SAR153191 (REGN88)(DRUG)
tocilizumab(DRUG)