Study of the Safety and Biologic Activity of AL01211 in Treatment Naive Males With Classic Fabry Disease

Summary

This is a Phase II, open-label study designed to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of AL01211 in male subjects with classic Fabry disease who have never received any treatment (eg. ERT or chaperone therapy). Eligible subjects will receive 182 days (26 weeks) of study treatment as the primary study period followed by an extension period. The total study duration for a subject is up to at most 2 years including the primary period of 26 weeks.

Timeline

Start

2023-10-25

Primary completion

2024-12

Completion

2026-06

Drugs

Indications