NCT04731324

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

A Phase 1, Prospective Open Label, Single Dose, Single Arm Study of ZYIL1 Administered Via Oral Route to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Adult Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 single-oral dose administration of ZYIL1 to healthy subjects aged between 18-55 years old (Both Inclusive). It will be conducted in up to 7 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 single oral dose of ZYIL1 on Day 1. In this study each cohort containing six subjects will be given a single oral dose of ZYIL1 in ascending manner. Initially, up to 3 cohorts of 18 subjects will be enrolled and dosed. Interim analysis will be done after completion of three cohorts and submitted to Central Licensing Authority of India(CLA). Further cohorts (i.e. cohort S4 onwards) will be conducted after obtaining approval of CLA. This is the first administration of ZYIL1 in humans; therefore, study design adjustments may be made based on emerging data from each dose cohort based on review of preliminary safety, tolerability, and PK results.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ZYIL1 capsule	NLRP3 inflammasome inhibitor

Timeline

• Start date: 2020-12-28
• Primary completion: 2021-06-12
• Completion: 2021-06-12
• First posted: 2021-01-29
• Last updated: 2021-06-18

Locations

1 site across 1 country: India