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drugset / Trial / NCT03582462

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of IONIS FXI-LRx in up to 84 Healthy Volunteers

NCT03582462 ↗

Phase 1 Completed 66 enrolled Ionis Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2018-07-09
Primary completion
2019-04-26
Completion
2019-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject IONIS FXI-LRX Antisense oligonucleotide — Subcutaneous

Indications

No indication recorded.