NCT03101878

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers

A Blinded, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 757456 Administered Subcutaneously to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS AGT-LRx in up to 82 Healthy Volunteers

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Ionis AGT-LRx	Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously
DRUG	Placebo	Saline .9%

Timeline

• Start date: 2017-04-05
• Primary completion: 2018-03-29
• Completion: 2018-08-01
• First posted: 2017-04-05
• Last updated: 2018-08-21

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study