NDLI: First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis

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First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis

Content Provider	Springer Nature Link
Author	Zhuang, Yanli Calderon, Cesar Marciniak, Stanley J Bouman Thio, Esther Szapary, Philippe Yang, Tong Yuan Schantz, Allen Davis, Hugh M. Zhou, Honghui Xu, Zhenhua
Copyright Year	2016
Abstract	The purpose of this study is to evaluate the pharmacokinetics, immunogenicity, safety, and tolerability of guselkumab, a human monoclonal antibody with high affinity and specificity for binding to interleukin-23.In this first-in-human, phase 1, randomized study, a single intravenous (IV; 0.03–10 mg/kg) or subcutaneous (SC; 10–300 mg) dose of guselkumab was administered to 47 healthy subjects, and a single SC dose (placebo, 10, 30, 100, 300 mg) was administered to 24 patients with moderate-to-severe psoriasis.Mean maximum observed serum concentration and area under the zero-to-infinity serum concentration-time curve of guselkumab increased in an approximately dose-proportional manner over the dose range of 0.03–10 mg/kg following a single IV administration or 10–300 mg following a single SC administration. Mean clearance and volume of distribution ranged from 3.62–6.03 mL/day/kg and 99.38–123.22 mL/kg, respectively. Mean half-life ranged from 12 to 19 days in healthy subjects and patients with psoriasis. Among guselkumab-treated subjects/patients, 1/30 (3.3 %) healthy subjects in the IV group, 0/6 healthy subjects in the SC group, and 1/20 (5.0 %) patients with psoriasis tested positive for antibodies to guselkumab. No clinically significant adverse events were identified in this study.Guselkumab pharmacokinetic profiles were generally comparable between healthy subjects and patients with psoriasis. Guselkumab, administered as an IV infusion or SC injection, was well tolerated in healthy subjects and patients with psoriasis.
Starting Page	1303
Ending Page	1310
Page Count	8
File Format	PDF
ISSN	00316970
Journal	European Journal of Clinical Pharmacology
Volume Number	72
Issue Number	11
e-ISSN	14321041
Language	English
Publisher	Springer Berlin Heidelberg
Publisher Date	2016-08-11
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Anti-interleukin-23 Monoclonal antibody Guselkumab First-in-human Pharmacokinetics Safety Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis

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