Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05186051
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2021-12-23
Brief Title:
A Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes CAPS
Sponsor:
Zydus Lifesciences Limited
Organization:
Zydus Lifesciences Limited
Study Overview
Official Title:
A Phase 2a Prospective Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes CAPS
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ZYIL1 is expected to show benefit in patients with CAPS The present study aims to determine the safety tolerability pharmacokinetics and pharmacodynamics of ZYIL1 when administered to subjects with CAPS
Detailed Description:
This is a phase 2a prospective open-label study Primary objective of the study is to determine safety and tolerability profile of twice daily oral administration of ZYIL1 administered for 7 days The study will be conducted in 3 subjects having CAPS as per eligibility criteria The study will be divided in three periods Screening Period Run-in Period and Study Period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None