None listed
Conditions
Brief summary
Study C2011-0301 is the first study in man for SAN-300. SAN-300 is being developed for the treatment of rheumatoid arthritis. SAN-300 will be administered intravenously in 9 cohorts and subcutaneously in 3 cohorts. Approximately 66 healthy volunteers and approximately 8 patients with active rheumatoid arthritis will be enrolled to receive a single dose of SAN-300 or Placebo. Participation in the study is approximately 1 month, including dosing and follow-up visits. 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.
Interventions
SAN-300 is a humanized anti-VLA-1 MAb. Eight cohorts of healthy subjects, plus 1 cohort of patients with rheumatoid arthritis, will receive single doses ranging from 0.03 mg/kg to 2 mg/kg, intravenously infused over 4 hours. Additionally, 3 Cohorts of healthy subjects will receive a single dose of SAN-300 by subcutaneous injection (an injection just beneath the skin). (The dose of SAN-300 in each Cohort is listed below: Cohort A (healthy subjects): 0.03 mg/kg Cohort B (healthy subjects): 0.1 mg/
SAN-300 is a humanized anti-VLA-1 MAb. Eight cohorts of healthy subjects, plus 1 cohort of patients with rheumatoid arthritis, will receive single doses ranging from 0.03 mg/kg to 2 mg/kg, intravenously infused over 4 hours. Additionally, 3 Cohorts of healthy subjects will receive a single dose of SAN-300 by subcutaneous injection (an injection just beneath the skin). (The dose of SAN-300 in each Cohort is listed below: Cohort A (healthy subjects): 0.03 mg/kg Cohort B (healthy subjects): 0.1 mg/kg Cohort C (healthy subjects): 0.3 mg/kg Cohort D (healthy subjects): 1.0 mg/kg Cohort E (healthy subjects): 0.6 mg/kg Cohort F (healthy subjects): 0.8 mg/kg Cohort G (healthy subjects): 1.0 mg/kg Cohort H (healthy subjects): 2.0 mg/kg Cohort I (Rheumatoid Arthritis patients) 2.0 mg/kg. The subcutaneous cohorts are; Cohort J (healthy subjects): 2 mg/kg Cohort K (healthy subjects): 4 mg/kg Cohort L (healthy subjects): 6 mg/kg
Sponsors
Santarus, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed