NCT05402384

AVTX-801 D-galactose Supplementation in SLC35A2-CDG

Evaluation of Efficacy and Safety of D-galactose Supplementation in SLC35A2-CDG, a Disorder of Hypogalactosylation

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Eva Morava-Kozicz · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of AVTX-801 in subjects with SLC35A2-CDG

Conditions

• SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation

Interventions

Type	Name	Description
DRUG	AVTX-801	Medical grade D-galactose dosage:2.0 g/kg/day
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2027-01-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2022-06-02
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study