A Phase 1 interventional study of ION904 and Placebo in Healthy Volunteers, sponsored by Ionis Pharmaceuticals, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Ionis Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety and tolerability of ION904.
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.
Ionis Pharmaceuticals, Inc. is the lead sponsor of 116 studies on the registry; 10 are open to participants now.
Of its 48 completed or terminated interventional studies of FDA-regulated products, 21 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Concomitant medication restrictions: over-the-counter or prescription medications within 14 days, prior to dosing on Day 1. Accepted exceptions are:
Single ascending dose of ION904 will be administered by SC injection on Day 1.
Drug: ION904
Placebo (0.9% sterile saline) will be administered by SC injection on Day 1.
Drug: Placebo
ION904 will be administered by SC injection.
Placebo (0.9% sterile saline) will be administered by SC injection.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Up to Day 85
Severity and dose relationship of TEAE
Time frame: Up to Day 85
Severity and dose relationship of clinically significant changes in laboratory values
Time frame: Up to Day 85
Severity and dose relationship of clinically significant changes in ECG
Time frame: Up to Day 85
Changes in the Level of ION904 Target Biomarker
Time frame: Up to Day 85
Cmax: Maximum Observed Plasma Concentration of ION904
Time frame: Up to Day 85
Tmax: Time to Reach the Maximum Plasma Concentration of ION904
Time frame: Up to Day 85
t½λz: Plasma Elimination Half-life of ION904
Time frame: Up to Day 85
AUC0-t: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t for ION904
Time frame: Up to Day 85
Urine 0-24 Hour (hr) Excretion of ION904
Time frame: Up to 24 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ionis Pharmaceuticals, Inc.