NCT04731623

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION904

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending, Dose-Escalation, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION904 Administered Subcutaneously to Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of ION904.

Detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study of ION904 in up to 72 participants. Following a Screening Period of up to 28 days, eligible healthy participants will be randomized to treatment and receive a single, subcutaneous (SC) dose of the assigned study drug. Participants will be followed for up to 13 weeks after dosing.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ION904	ION904 will be administered by SC injection.
DRUG	Placebo	Placebo (0.9% sterile saline) will be administered by SC injection.

Timeline

• Start date: 2021-02-26
• Primary completion: 2021-08-12
• Completion: 2021-09-11
• First posted: 2021-02-01
• Last updated: 2022-08-09

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study