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9 Diseases |  |
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0 Trials |  |
9 News |  |
- | ISIS 353512 / Ionis
Journal: Early-Stage Identification and Avoidance of Antisense Oligonucleotides Causing Species-Specific Inflammatory Responses in Human Volunteer Peripheral Blood Mononuclear Cells. (Pubmed Central) - Aug 22, 2022
P1, P2
The development of this assay was initiated when ISIS 353512 targeting the messenger ribonucleic acid for human C-reactive protein (CRP) was tested in a phase I clinical trial, in which healthy human volunteers unexpectedly experienced increases in interleukin-6 (IL-6) and CRP...The IL-6 induction was inhibited by chloroquine pretreatment of PBMCs and the nature of ASOs suggested that the response is mediated by a Toll-like receptor (TLR), in all likelihood TLR9...The PBMC assay using discriminator donors was shown to be reproducible, allowing to assess reliably the immune potential of ASOs by comparison to known benchmark ASO controls that were previously shown to be either safe or inflammatory in clinical trials. Clinical Trial registration numbers: NCT00048321 NCT00330330 NCT00519727.
- ISIS 353512 / Ionis
Trial completion, Enrollment change: ASET: Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation (clinicaltrials.gov) - Aug 27, 2015
P2, N=7, Completed, Sponsor: Isis Pharmaceuticals
Clinical Trial registration numbers: NCT00048321 NCT00330330 NCT00519727. Active, not recruiting --> Completed | N=20 --> 7
- | ISIS 353512 / Ionis
Enrollment closed: ASET: Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation (clinicaltrials.gov) - Jan 30, 2014
P2, N=20, Active, not recruiting, Sponsor: Isis Pharmaceuticals
Active, not recruiting --> Completed | N=20 --> 7 Recruiting --> Active, not recruiting
- |||| ISIS 353512 / Ionis
Trial completion: Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis (clinicaltrials.gov) - May 15, 2013
P2, N=51, Completed, Sponsor: Isis Pharmaceuticals
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | ISIS 353512 / Ionis
New P2 trial: ASET: Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation (clinicaltrials.gov) - Oct 17, 2012
P2, N=20, Active, not recruiting, Sponsor: Isis Pharmaceuticals
- ||||| ISIS 353512 / Ionis
New P2 trial: Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis (clinicaltrials.gov) - Aug 9, 2011
P2, N=51, Completed, Sponsor: Isis Pharmaceuticals