RecruitingPhase 2Phase 3NCT07378644

Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease

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


Sponsor

Skyhawk Therapeutics, Inc.

Enrollment

400 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SKY-0515 and a drug called SKY-0515 Placebo for people with huntington disease. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 25 Years and older.

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

DRUGSKY-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

DRUGSKY-0515 Placebo

Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental


Locations(8)

Buenos Aires British Hospital

CABA, Buenos Aires, Argentina

Instituto Argentino de Investigación Neurológica

CABA, Buenos Aires, Argentina

CINME Centro de Investigaciones Metabólicas

CABA, Buenos Aires, Argentina

Fundación Scherbovsky

Mendoza, Mendoza Province, Argentina

PSEG Centro de Pesquisa Clinica

São Paulo, São Paulo, Brazil

North York General Hospital

Toronto, Ontario, Canada

Pineo Medical Ecosystem

Tbilisi, Georgia

Simon Khechinashvili University Hospital

Tbilisi, Georgia

View Full Details on ClinicalTrials.gov

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NCT07378644


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