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

NCT05981040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Dr. Deven Parmar, MD,FCP · Zydus Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2024-06-26
Completion
2024-06-26

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981040 on ClinicalTrials.gov