A randomized, placebo controlled, double blind, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single escalating doses of SAN-300 when administered to healthy subjects and patients with rheumatoid arthritis
- Conditions
- Active Rheumatoid ArthritisInflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12611000123943
- Lead Sponsor
- Santarus, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 74
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety and tolerability after a single dose of SAN-300 through 1 month after dosing. <br><br>Safety and tolerability will be assessed by serum chemistry, hematology, urinalysis, physical exam, vital signs, and electrocardiogram.[Subjects will receive the dose of study drug and remain in the clinic for 24 hours. There are 5 follow up visits conducted over 1 month (Day 3, Day 8, Day 15, Day 22 and Day 29).]
- Secondary Outcome Measures
Name Time Method Characterization of the pharmacokinetics and pharmacodynamics after a single dose of SAN-300, through 1 month after dosing[Subjects will receive the dose of study drug and remain in the clinic for 24 hours. There are 5 follow up visits conducted over 1 month (Day 3, Day 8, Day 15, Day 22 and Day 29).]