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Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Sponsor: Skyhawk Therapeutics, Inc.
Summary
The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.
Official title: A Phase 2/3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Key Details
Gender
All
Age Range
25 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-01-06
Completion Date
2029-08
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
SKY-0515
Type: Small molecule Dosage Level(s): Low, mid, high Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental
SKY-0515 Placebo
Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental
Locations (2)
Pineo Medical Ecosystem
Tbilisi, Georgia
Simon Khechinashvili University Hospital
Tbilisi, Georgia