NCT04972188

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ZYIL1 Following Oral Administration in Healthy Volunteers

A Phase I, Prospective, Open Label, Multiple Dose Study Of ZYIL1 Administered Via Oral Route To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

ZYIL1 is a novel oral selective NLRP3 inflammasome inhibitor which prevents NLRP3-induced ASC oligomerization, thus inhibiting NLRP3 inflammasome pathway. ZYIL1 is expected to show benefit in patients demonstrating cytokine, like IL1β flare, including those exhibiting cytokine storm related to COVID-19 and other viral inflammatory diseases.

Detailed description

It is an open label, study designed to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following a multiple-oral dose administration of ZYIL1 to healthy subjects aged between 18-55 years old (Both Inclusive). It will be conducted in up to 3 cohorts of 6 subjects each. Each cohort will be enrolled within a 28 day screening period to ensure subjects meet all the inclusion criteria and none of the exclusion criteria. Subjects will be administered multiple oral dose of ZYIL1 from day 1 to till day 14.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ZYIL1 Capsule	NLRP3 inflammasome inhibitor

Timeline

• Start date: 2021-07-12
• Primary completion: 2021-10-25
• Completion: 2021-10-25
• First posted: 2021-07-22
• Last updated: 2021-11-16

Locations

1 site across 1 country: India