NCT03263507

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to Healthy Volunteers

A Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 721744, an Antisense Oligonucleotide Inhibitor of PKK, Administered Subcutaneously to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen administered subcutaneously to Healthy Volunteers

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Placebo	Saline .9%
DRUG	Donidalorsen	Donidalorsen administered subcutaneously

Timeline

• Start date: 2017-08-28
• Primary completion: 2018-10-09
• Completion: 2018-10-09
• First posted: 2017-08-28
• Last updated: 2022-08-04

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study