ACTRN12611000123943CompletedPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Santarus, Inc.
- Enrollment
- 74
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
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.
Investigators
Similar Trials
Completed
Phase 1
A Trial in Healthy Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRAX-944Essential TremorNeurological - Other neurological disordersACTRN12620000675921Praxis Precision Medicines24
Completed
Phase 1
Study to assess the safety, tolerability and pharmacokinetics of DSP-2230 in humansPeripheral neuropathic painSigns and SymptomsISRCTN07951717Sunovion Pharmaceuticals Europe Ltd156
Suspended
Phase 1
Drug interaction assessment of GSK3882347 in healthy participants aged 18 to 65 yearsHealthy volunteer drug interaction studyISRCTN16147016GlaxoSmithKline (United Kingdom)30
Completed
Not Applicable
A phase 1 study in healthy volunteers to determine the dermatopharmacokinetics of topically applied diclofenac in combination with the novel penetration enhancer Tocopheryl Phosphate Mixture (TPM), compared with Votaren(registered trademark) gelMuscular or joint pain relief in healthy volunteers currently experiencing no painOther - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12609000505202Phosphagenics Limited24
Completed
Phase 1
A Trial in Healthy Participants to Evaluate the Pharmacokinetics, Safety, Tolerability and Food Effects of Multiple Forms of PRAX-114.DepressionACTRN12620000522910Praxis Precision Medicines Australia, Pty Ltd85