NCT03165864

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered Subcutaneously to Healthy Volunteers

A Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 702843 Administered Subcutaneously to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (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 IONIS TMPRSS6-Lrx Administered Subcutaneously for up to 44 Healthy Volunteers

Conditions

• Thalassemia

Interventions

Type	Name	Description
DRUG	IONIS TMPRSS6-Lrx	Ascending single and multiple doses of IONIS TMPRSS6-Lrx administered subcutaneously
OTHER	Placebo	Saline .9%

Timeline

• Start date: 2017-05-09
• Primary completion: 2018-09-25
• Completion: 2018-09-25
• First posted: 2017-05-24
• Last updated: 2019-01-22

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study