A phase 1 study of healthy subjects and patients with rheumatoid arthritis receiving single doses of SAN-300 or placebo to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SAN-300

Santarus, Inc.0 个研究点目标入组 74 人开始时间: 2011年2月3日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Healthy Subjects:
•-Healthy Men and Women
•-18 to 55 years of age
•-Those who are of child-bearing potential must be willing to use adequate birth control measures during the study.
•Participation in the study lasts approximately 1 month.
•Rheumatoid Arthritis (RA) Patients:
•-18 to 65 years of age
•-Diagnosis of RA for greater than or equal to 6 months; swollen joint count greater than or equal to 5 and tender joint count greater than or equal to 5; on current background therapy.
•-Those who are of child-bearing potential must be willing to use adequate birth control measures during the study.
•Participation in the study lasts approximately 1 month.

•Healthy Subjects and Patients with Rheumatoid Arthritis:
•-History of malignancy, carcinoma, other major diseases or severe allergic reactions.
•-History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases.
•-History of opportunistic infection or recurrent clinically significant infections.
•-History of malaria or travel to a malaria endemic region within one year.
•-History of positive blood test for hepatitis C, hepatitis B or HIV.
•-History of tuberculosis or positive QuantiFERON-TB Gold test.
•-History of drug or alcohol abuse.
•-Any live immunization/vaccination within 4 weeks before study drug administration.
•Women who are pregnant or breastfeeding will be excluded.
•Rheumatoid Arthritis Patients:
•-Functional Class IV as defined by ACR classification.
•-History of significant systemic involvement secondary to RA.

发起方