RecruitingPhase 1NCT06150716

Orbit Study: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered ION356 in Participants With Pelizaeus Merzbacher Disease (PMD)

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION356 in Patients With Pelizaeus Merzbacher Disease


Sponsor

Ionis Pharmaceuticals, Inc.

Enrollment

24 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to evaluate the safety and tolerability of ION356.


Eligibility

Sex: MALEMin Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ION356 for people with pelizaeus-merzbacher disease. The study is currently recruiting participants at 7 locations. People eligible for this study include men aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGION356

Administered as intrathecal (IT) injection.


Locations(7)

Ionis Investigative Site

Atlanta, Georgia, United States

Ionis Investigative Site

Philadelphia, Pennsylvania, United States

Ionis Investigative Site

Salt Lake City, Utah, United States

Ionis Investigative Site

Le Kremlin-Bicêtre, France

Ionis Investigative Site

Göttingen, Germany

Ionis Investigative Site

Tokyo, Japan

Ionis Investigative Site

Amsterdam, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06150716


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