A Phase 1 interventional study of IONIS FXI-LRx and Placebo in Healthy Participants, sponsored by Ionis Pharmaceuticals, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Ionis Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
To evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics, including Factor XI activity and antigen levels, activated partial thromboplastin time, prothrombin time and international normalized ratio of single and multiple doses of Factor XI antisense inhibitor administered subcutaneously to healthy volunteers.
This will be a Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study conducted at a single center. The study consists of 4 escalating single-dose cohorts (n = 8 per cohort, randomized 3 IONIS FXI-LRx active:1 placebo), 3 escalating multiple-dose cohorts with weekly Study Drug (IONIS FXI-LRx or placebo) administration for 8 healthy volunteers per cohort, randomized 3 active:1 placebo, and 1 multiple-dose cohort of 10 healthy volunteers randomized 3 active:2 placebo with Study Drug administration every 4 weeks.
Approximately 66 healthy volunteers are planned to be enrolled in this study. Additional healthy volunteers may be added to better assess the safety, tolerability or pharmacokinetic profile of IONIS FXI-LRx to meet study objectives.
Ionis Pharmaceuticals, Inc. is the lead sponsor of 116 studies on the registry; 10 are open to participants now.
Of its 48 completed or terminated interventional studies of FDA-regulated products, 21 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Clinically-significant abnormalities in medical history, screening laboratory results, physical examination that would render a subject unsuitable for inclusion. Including but not limited to:
Ascending single and multiple doses of IONIS FXI-LRx by subcutaneous (SC) injection.
Drug: IONIS FXI-LRx
Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator.
Drug: Placebo
Ascending single and multiple doses of IONIS FXI-LRx by subcutaneous (SC) injection
Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator
Safety and Tolerability as Measured by the Number of Participants with Treatment-Emergent Adverse Events
Time frame: Up to 232 Days
Cmax: maximum observed drug concentration in plasma of IONIS FXI-LRx
Time frame: Up to 232 Days
Tmax: time taken to reach maximal concentration in plasma of IONIS FXI-LRx
Time frame: Up to 232 Days
AUC: area under the plasma concentration time curve for IONIS FXI-LRx
Time frame: Up to 232 Days
Change from Baseline in Factor XI antigen levels
Factor XI antigen levels will be measured with a reference range of 0.72-1.63 U/mL
Time frame: Up to 232 Days
Change from Baseline in Factor XI activity levels
Factor XI activity levels will be measured with a reference range of 0.73-1.45 U/mL
Time frame: Up to 232 Days
Change from Baseline in activated partial thromboplastin time (aPTT)
Time frame: Up to 232 Days
Change from Baseline in prothrombin time (PT)
Time frame: Up to 232 Days
Change from Baseline in the international normalized ratio (INR)
Time frame: Up to 232 Days
Plan to share: No
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Ionis Pharmaceuticals, Inc.