Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07378644
PHASE2/PHASE3

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

Sponsor: Skyhawk Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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