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
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.
74 participants
Mar 7, 2011
Interventional
Conditions
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.
Eligibility
Inclusion Criteria10
- Healthy Subjects:
- Healthy Men and Women
- 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:
- 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 Criteria13
- 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.
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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/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
Locations(1)
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ACTRN12611000123943