NCT04302064

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending and Multiple Doses of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Healthy Japanese Participants

A Randomized, Double-Blinded, Placebo-Controlled, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending and Multiple Doses of ION-682884 in Healthy Japanese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of single and potentially multiple doses of Eplontersen administered subcutaneously (SC) to healthy Japanese participants.

Detailed description

This is a single-center, double-blinded, placebo-controlled study in up to 44 participants. Participants will be randomized to receive three subcutaneous single-ascending doses and potentially multiple doses of Eplontersen or placebo.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Eplontersen	Eplontersen administered SC
DRUG	Placebo	Eplontersen-matching placebo administered SC

Timeline

• Start date: 2020-04-23
• Primary completion: 2020-09-10
• Completion: 2020-09-10
• First posted: 2020-03-10
• Last updated: 2022-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study