NCT05981040View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 9, 2023

Primary Completion Date

June 26, 2024

Study Completion Date

June 26, 2024

Conditions
Amyotrophic Lateral Sclerosis
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

Trial Locations (7)

422003

Surya Multispecialty Hospital, Nashik

Unknown

Zydus Hospitals & Healthcare Research, Ahmedabad

Rhythm heart institute, Vadodara

BrainS Super Speciality Hospital, Bengaluru

KIMS-Kingsway Hospitals, Nagpur

CIMET's Inamdar Multispeciality Hospital, Pune

Sir Ganga Ram Hospital, New Delhi

All Listed Sponsors
lead

Zydus Lifesciences Limited

INDUSTRY

NCT05981040 - Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Patients With Amyotrophic Lateral Sclerosis | Biotech Hunter | Biotech Hunter