Pharmacokinetics and pharmacodynamics of mibavademab (a leptin receptor agonist): Results from a first‐in‐human phase I study

Mibavademab (previously known as REGN4461), a fully human monoclonal antibody, is being investigated for the treatment of conditions associated with leptin deficiency. Here, we report pharmacokinetics (PKs), pharmacodynamics, and immunogenicity from a phase I study in healthy participants (NCT035305...

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Veröffentlicht in:Clinical and translational science 2024-04, Vol.17 (4), p.e13762-n/a
Hauptverfasser: Gewitz, Andrew, Mendell, Jeanne, Wang, Yuhuan, Harris, Charles, Olenchock, Benjamin A., Podgrabinska, Simona, Zheng, Wenjun, Zhao, An, Pan, Hao, Vanhoutte, Frédéric, Davis, John D.
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Sprache:eng
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Zusammenfassung:Mibavademab (previously known as REGN4461), a fully human monoclonal antibody, is being investigated for the treatment of conditions associated with leptin deficiency. Here, we report pharmacokinetics (PKs), pharmacodynamics, and immunogenicity from a phase I study in healthy participants (NCT03530514). In part A, lean or overweight healthy participants were randomized to single‐ascending‐dose cohorts of 0.3, 1.0, 3.0, 10, and 30 mg/kg intravenous (i.v.), or 300 and 600 mg subcutaneous doses of mibavademab or placebo. In part B, overweight or obese participants were randomized to receive multiple doses of mibavademab (15 mg/kg i.v. loading dose and 10 mg/kg i.v. at weeks 3, 6, and 9) or placebo, stratified by body mass index and baseline leptin levels: low leptin (
ISSN:1752-8054
1752-8062
1752-8062
DOI:10.1111/cts.13762