NCT05981040

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	ZYIL1 capsules 25 mg and 50 mg Placebo	ZYIL1 capsules 25 mg for oral administration + matching placebo of 50 mg ZYIL1 capsule
DRUG	ZYIL1 capsules 50 mg and 25 mg Placebo	ZYIL1 capsules 50 mg for oral administration + matching placebo of 25 mg ZYIL1 capsule
DRUG	ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mg	ZYIL1 capsules 25 mg for oral administration + ZYIL1 capsules 50 mg for oral administration
DRUG	Matching placebo 25 mg and Matching placebo 50 mg	Matching placebo of 25 mg ZYIL1 capsule + Matching placebo of 50 mg ZYIL1 capsule

Timeline

• Start date: 2023-11-09
• Primary completion: 2024-06-26
• Completion: 2024-06-26
• First posted: 2023-08-08
• Last updated: 2024-12-19

Locations

7 sites across 1 country: India