CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
ION-682884 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03728634
NCT03728634Phase 2Completed

This Was a Phase 1/2, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study Conducted at a Single Center for the Healthy Volunteer Cohorts in up to 56 Participants. It Consisted of 1 Single-dose Cohort and 3 Multiple-dose Cohorts (n = 12 Per Cohort, 10 Active:2 Placebo). The Open-label, hATTR Patient Cohort Portion of the Study Was Conducted at Multiple Centers.

Ionis Pharmaceuticals, Inc.·interventional·Posted Nov 2, 2018·Updated Dec 19, 2022

In Brief

A Phase 2 clinical trial evaluating ION-682884, Placebo, and 1 other intervention for Healthy Volunteers and hATTR Amyloidosis. Completed, enrolled 47 participants across 1 site.

Detailed Summary

To evaluate the safety and tolerability, as well as the pharmacokinetic and pharmacodynamic profiles of single and multiple doses of Eplontersen administered subcutaneously to healthy volunteers and patients with Hereditary Transthyretin-Mediated Amyloidosis (hATTR ).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2, 2018
Enrollment StartDec 21, 2018
Primary CompletionFeb 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.7 years ago

Interventions

ION-682884drug

ION-682884 administered SC

Placebodrug

Placebo comparator calculated volume to match ION-682884 administered SC

Vitamin Adietary

Oral supplement