First‐In‐Human, Randomized, Placebo‐Controlled, SAD and MAD Trial to Evaluate Safety, Tolerability, and PK/PD Modeling of Potravitug in Healthy Adults

First‐In‐Human, Randomized, Placebo‐Controlled, SAD and MAD Trial to Evaluate Safety, Tolerability, and PK/PD Modeling of Potravitug in Healthy Adults

ABSTRACT BK polyomavirus (BKPyV) affects 10%–30% of kidney‐transplant recipients receiving immunosuppressive therapy, potentially leading to nephropathy, graft dysfunction, graft loss, and increased mortality. Despite the medical need, no targeted therapies exist. This first‐in‐human trial evaluated...

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Bibliographic Details
Main Authors: Marcus May, Julia K. Bialek‐Waldmann, Andrew Wright, Scott Gruver, Joshuaine Grant, Barbara Eicher, Jemima Seidenberg, Gerald P. Parzmair, Juergen Beck
Format: Article
Language:English
Published: Wiley 2025-08-01
Series:Clinical and Translational Science
Subjects:
BK polyomavirus
monoclonal antibody
phase I
PK/PD modeling
Online Access:https://doi.org/10.1111/cts.70316
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https://doi.org/10.1111/cts.70316

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