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

Phase 1 Completed 30 enrolled Zydus Lifesciences Limited

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2020-12-28
Primary completion: 2021-06-12
Completion: 2021-06-12

Publications

Parmar DV, Kansagra KA, Momin T, Patel HB, Jansari GA, Bhavsar J, Shah C, Patel JM, Ghoghari A, Barot A, Sharma B, Viswanathan K, Patel HV, Jain MR. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral NLRP3 Inflammasome Inhibitor ZYIL1: First-in-Human Phase 1 Studies (Single Ascending Dose and Multiple Ascending Dose). Clin Pharmacol Drug Dev. 2023 Feb;12(2):202-211. doi: 10.1002/cpdd.1162. Epub 2022 Sep 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Usnoflast	Small molecule	25 mg	Oral

Indications

No indication recorded.