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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 27, 2025

Primary Completion Date

May 31, 2027

Study Completion Date

December 31, 2027

Conditions
Huntington DiseaseHuntingtons Disease
Interventions
DRUG

SKY-0515

"Study Drug Name (INN): SKY-0515 Type: Drug (small molecule) Dosage Level(s): Low, mid, high Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 12 months~Use: Experimental Sourcing: SKY-0515 will be provided centrally by the Sponsor or subsidiary, or designee Packaging and Labeling: Study drug will be provided in blinded bottles labeled as required per country requirement. All packaging and labeling operations for the study drug will be performed according to current Good Manufacturing Practice for Medicinal Products and the relevant regulatory requirements."

DRUG

SKY-0515 Placebo

"Route of Administration: Oral Dosage~Frequency: Once daily~Blinded Treatment Duration: 12 months~Use: Experimental~Sourcing: SKY-0515 placebo will be provided centrally by the Sponsor or subsidiary, or designee~Packaging and Labeling: Study drug will be provided in blinded bottles labeled as required per country requirement. All packaging and labeling operations for the study drug will be performed according to current Good Manufacturing Practice for Medicinal Products and the relevant regulatory requirements"

Trial Locations (10)

1023

RECRUITING

Auckland City Hospital, Auckland

2145

RECRUITING

Westmead Hospital, Westmead

2305

RECRUITING

John Hunter Hospital, New Lambton Heights

3050

RECRUITING

The Royal Melbourne Hospital, Parkville

3162

RECRUITING

Calvary Health Care Bethlehem, Caulfield South

4006

RECRUITING

The University of Queensland, Herston

5042

RECRUITING

Flinders Medical Centre, Adelaide

6009

RECRUITING

The Perron Institute for Neurology and Translational Science (Perron Institute), Nedlands

6021

RECRUITING

Wellington Hospital, Wellington

8011

RECRUITING

Christchurch Neurology Trials Limited, Christchurch

All Listed Sponsors
lead

Skyhawk Therapeutics, Inc.

INDUSTRY

NCT06873334 - Study of SKY-0515 for Safety, Efficacy, and Pharmacodynamics in Participants With Huntington's Disease | Biotech Hunter | Biotech Hunter