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Clinical Trial Summary

Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in patients with Amyotrophic Lateral Sclerosis (ALS).


Clinical Trial Description

This Phase 2 open label trial seeks to investigate whether a novel therapy named 3K3A-APC is safe and potentially effective in patients with Amyotrophic Lateral Sclerosis (ALS). A total of 16 patients with ALS will be enrolled into 2 dose cohorts with five doses of 15mg or 30mg doses given 12 hours apart in each cohort. The primary study outcomes are to ensure the safety and tolerability of 3K3AAPC in ALS patients, and to determine whether 3K3A-APC is able to reduce the pathological changes that might possibly cause ALS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05039268
Study type Interventional
Source Macquarie University, Australia
Contact Richard Gan, MN, BSc(Med)
Phone +61 2 9812 3739
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date October 2021
Completion date January 2022

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