A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants

Healthy Participants Clinical Trial

Official title: A Randomized Double-blind, Placebo-controlled, Non-confirmatory Study to Assess Safety, Tolerability, PK, and PD of Single Ascending and Multiple Doses of ISIS 681257 in Healthy Japanese Participants

Status Completed

Clinical Trial Summary

The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple subcutaneous (SC) doses of Pelacarsen (ISIS 681257) in healthy Japanese participants.

Clinical Trial Description

This was a randomized, placebo-controlled, participant and investigator-blinded, single ascending and multiple-dose study of Pelacrsen (ISIS 681257) in up to 29 healthy Japanese male and female participants. The study was conducted in two parts:1) Single ascending dose (SAD) including up to a 28-day screening period, a baseline period, dose with study drug on Day 1, a 2-day (48 hours) post-dose in-patient observation period, followed by an out-patient observation period up to Day 90; 2) Multiple doses (MD) including up to a 28-day screening period, a baseline period, dose with study drug up to Day 85, a 2-day (48 hours) post-dose in-patient observation period, followed by an out-patient observation period up to Day 204.

In the SAD period, participants were randomized to receive single dose of Pelacarsen or placebo.

Upon completion of the SAD period participants were randomized to receive multiple doses of Pelacarsen. ;

Related Conditions & MeSH terms

• Healthy Participants

• NCT number: NCT05337878
• Study type: Interventional
• Source: Ionis Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2018
• Completion date: December 18, 2019