NCT04934891

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION547

A Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION547 Administered Subcutaneously to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of the antisense inhibitor ION547 administered subcutaneously (SC) in healthy participants.

Detailed description

This is a Phase 1, double-blind, randomized, placebo-controlled, dose escalation study of ION547 in up to 76 participants. Participants will be randomized to receive single and multiple doses of ION547 or placebo SC. The maximum length of participation in the study will be approximately 34 weeks.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ION547	ION547 will be administered by SC injection.
DRUG	Placebo	ION547-matching placebo will be administered by SC injection.

Timeline

• Start date: 2021-03-24
• Primary completion: 2022-09-14
• Completion: 2022-09-14
• First posted: 2021-06-22
• Last updated: 2022-09-23

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study