Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZY-IL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes
© 2023 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
Clinical pharmacology in drug development - 13(2024), 2 vom: 30. Feb., Seite 152-159 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hissaria, Pravin [VerfasserIn] |
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| Links: |
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| Themen: |
CAPS |
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| Anmerkungen: |
Date Completed 07.02.2024 Date Revised 16.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/cpdd.1318 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM360772439 |
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| 520 | |a © 2023 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a oral NLRP3 inflammasome inhibitor | |
| 650 | 4 | |a pharmacodynamics | |
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| 700 | 1 | |a Patel, Hardik |e verfasserin |4 aut | |
| 700 | 1 | |a Momin, Taufik |e verfasserin |4 aut | |
| 700 | 1 | |a Ghoghari, Ashok |e verfasserin |4 aut | |
| 700 | 1 | |a Patel, Harilal |e verfasserin |4 aut | |
| 700 | 1 | |a Sharma, Bhavesh |e verfasserin |4 aut | |
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