Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Classic Galactosemia

In brief

This study is a first-in-human, randomized, placebo-controlled, 4-Part, single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy adult subjects and adult subjects with Classic Galactosemia.

Key facts

Study ID

NCT04117711

Run by

Applied Therapeutics, Inc.

People needed

114

Starts

2019-06-21

Expected to finish

2021-12-14

Last updated by the study team

2024-05-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of Classic Galactosemia confirmed by evidence of absent or significantly decreased (<1%) GALT activity in red blood cells and by GALT gene analysis
• Urine galactitol >100 mmol/mol creatinine
• Galactose-restricted diet

You may not qualify if…

• Complications of CG resulting in disability that, in the opinion of the Investigator, may prevent the subject from completing all study requirements (e.g., severe neurological deficits, severe cognitive impairment, or severe language difficulty).
• Renal disease (eGFR < 90 mL/min/1.73 m2 or albuminuria).

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• ICON Clinical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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