Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZY-IL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes.
Clin Pharmacol Drug Dev
; 13(2): 152-159, 2024 02.
Article
in En
| MEDLINE
| ID: mdl-37577847
ABSTRACT
We present the first results of the proof-of-concept phase 2a study of oral NLRP3 inflammasome inhibitor in subjects with cryopyrin-associated periodic syndromes (CAPS). Three adult subjects with a confirmed diagnosis of CAPS were enrolled and administered 50 mg of ZYIL1 twice daily for 7 days. A total of 5 treatment-emergent adverse events (TEAEs) were reported in 2 subjects. All 5 TEAEs were mild in severity and considered unrelated to the study drug. At steady state, the average plasma concentration and trough concentration ranged from 2.5 to 4.2 and 1.4 to 2.5 µg/mL, respectively. Inflammatory markers and disease activity (physician and patient global assessment score) decreased notably 12 hours post-last dose.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Cryopyrin-Associated Periodic Syndromes
Type of study:
Risk_factors_studies
Limits:
Adult
/
Humans
Language:
En
Journal:
Clin Pharmacol Drug Dev
Year:
2024
Document type:
Article
Affiliation country:
Australia