None listed
Conditions
Brief summary
Current treatments to control damaging immune responses during autoimmunity use broad immunosuppressive drugs associated with undesirable side effects. Alternative strategies to control damaging immune responses are desirable. DEN-181 offers a novel liposomal therapy that does not broadly suppress the immune system, with the associated increased risk of infectious complications, but rather is designed to specifically address the underlying pathology of Rheumatoid Arthritis by re-programming the immune system towards tolerance for improved patient outcomes and minimal side effects. This study is designed to assess the safety and tolerability of a single dose of DEN-181 in Rheumatoid Arthritis patients.
Interventions
Randomised double blind, placebo-controlled, single centre, single-dose escalation study of DEN-181 at three dose levels (4 active, 2 placebo per dose level).
DEN-181 is a liposomal formulation encapsulating two active pharmaceutical ingredients, calcitriol (0.6 ug/mL) and collagen II peptide (42 ug/mL; 15 amino acid peptide corresponding to collagen II protein 259-273 (Proline 273 Hydroxyproline substitution).
DEN-181 is given by subcutaneous injection at a volume of 100 uL, 300 uL or 1000 uL
Randomised double blind, placebo-controlled, single centre, single-dose escalation study of DEN-181 at three dose levels (4 active, 2 placebo per dose level). DEN-181 is a liposomal formulation encapsulating two active pharmaceutical ingredients, calcitriol (0.6 ug/mL) and collagen II peptide (42 ug/mL; 15 amino acid peptide corresponding to collagen II protein 259-273 (Proline 273 Hydroxyproline substitution). DEN-181 is given by subcutaneous injection at a volume of 100 uL, 300 uL or 1000 uL.
Sponsors
Dendright Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
The criteria for entry into the study are: 1. Diagnosis of rheumatoid arthritis made by a rheumatologist; 2. HLA-DRB1*0401+, HLA-DRB1*0101+ or HLA-DRB1*0401+HLA-DRB1*0101+ heterozygotes, homozygotes or compound heterozygotes; and ACPA+ (anti-CCP2>6); 3. Treatment with MTX at the same dose for at least 4 weeks prior to planned start of trial treatment; 4. Age 18-75 years (male or female) inclusive; 5. Patients must be informed of the investigational nature of this study and give voluntary written informed consent in accordance with the institutional and hospital guidelines; 6. With or without swollen joints; 7. Male or Female. Females of child-bearing potential must agree to use two effective forms of contraception from enrolment to completion of the study; 8. Blood glucose, CBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT not greater than 1.5 times out of normal range at entry and clinically insignificant in the opinion of the investigator; 9. Patients agree to forego vaccinations during the course of the study;
Exclusion criteria
The criteria for exclusion from the study are: 1. Malignancy; 2. An active inflammatory disease other than RA; 3. Currently receiving or have received treatment with >10mg prednisone daily within the last 2 weeks prior to screening; 4. Current or recent treatment (< 2 weeks prior) with any disease-modifying anti- rheumatic drugs other than methotrexate; 5. Serious infection requiring hospitalization within last 28 days; 6. Receipt of any live attenuated vaccines within 4 weeks prior to entry; 7. Major surgery within last 28 days; 8. Significant cardiovascular, renal, liver, neurological or skin disease; 9. Positive serology for HIV or infection with HBV or HCV; 10. Treatment with cytotoxic or immunomodulatory therapies such as radiotherapy, cyclophosphamide, mycophenolate, tacrolimus, PUVA, acitretin, cyclosporine or azathioprine; 11. Any known or suspected allergies to the study drug or its constituents including egg products; 12. Inadequate venous access to allow collection of blood samples; 13. History of drug or alcohol abuse; 14. Participation in another clinical study; 15. If, in the opinion of the PI, the subject appears not to be able to perform the needed responsibilities of participation in the clinical study.
Outcome results
None listed