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Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Patients With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
A Phase 2, Proof-of-concept, Placebo Controlled, Randomized, Multi-centre, Double Blind Study of ZYIL1 to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Summary

ZYIL1 is expected to show benefit in patients with Amyotrophic Lateral Sclerosis (ALS). The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects with ALS.

Clinical Trial Description

This is a proof-of-concept, placebo controlled, randomized, multi-centre,double blind study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with Amyotrophic Lateral Sclerosis following a twice daily oral administration of ZYIL1 or matching placebo to patients aged between 18 and 80 years (inclusive at screening). Treatment duration will be twelve (12) weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05981040
Study type Interventional
Source Zydus Lifesciences Limited
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 27, 2023
Completion date September 30, 2024
View Details
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