A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of a First-in-Human Engineered Cationic Peptide, PLG0206, Intravenously Administered in Healthy Subjects
David Huang, Despina Dobbins, Parviz Ghahramani, Ian Friedland, Jonathan Steckbeck
Abstract
In this first-in-human study, PLG0206, a novel engineered cationic antimicrobial peptide, was evaluated for safety, tolerability, and pharmacokinetics (PK) when intravenously (i.v.) administered as a single dose to healthy subjects. Six cohorts of 8 subjects each received escalating single i.v. infusions of PLG0206 at 0.05, 0.125, 0.25, 0.5, or 1 mg/kg dose or placebo over 1 to 4 h.
Topics & Concepts
PharmacokineticsPlaceboMedicineTolerabilityAdverse effectPharmacologyClinical trialAnesthesiaInternal medicinePharmacodynamicsDosingIncidence (geometry)Phases of clinical researchTherapeutic indexDose–response relationshipToxicityAntimicrobialAntimicrobial Peptides and ActivitiesPeptidase Inhibition and AnalysisAntimicrobial agents and applications