Tolerability, safety and pharmacokinetics of the [FGL.sub.L] peptide, a novel mimetic of neural cell adhesion molecule, following intranasal administration in healthy volunteers

Background: The FG loop peptide ([FGL.sub.L]), a novel mimetic of the neural cell adhesion molecule (NCAM), is in clinical development for neurodegenerative disorders such as Alzheimer's disease. Preclinical studies in rats, dogs and monkeys have demonstrated exposure in plasma and cerebrospina...

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Published in:Clinical pharmacokinetics 2007-04, Vol.46 (4), p.351
Main Authors: Anand, Ravi, Seiberling, Michael, Kamtchoua, Thierry, Pokorny, Rolf
Format: Article
Language:English
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Summary:Background: The FG loop peptide ([FGL.sub.L]), a novel mimetic of the neural cell adhesion molecule (NCAM), is in clinical development for neurodegenerative disorders such as Alzheimer's disease. Preclinical studies in rats, dogs and monkeys have demonstrated exposure in plasma and cerebrospinal fluid after parenteral or intranasal administration of [FGL.sub.L], with no systemic toxicity. This article reports on the results of the first administration of [FGL.sub.L] in humans. Objective: To determine the tolerability, safety and pharmacokinetics of ascending, single intranasal doses of [FGL.sub.L] 25, 100 and 200mg in healthy subjects. Methods: In an 8-day, open-label, phase I study, 24 healthy male volunteers (mean age 42 [range 24-55] years) received single intranasal doses of [FGL.sub.L] (25, 100 and 200mg) in accordance with an ascending dose, sequential-cohort design. Results: All three intranasal doses of [FGL.sub.L] were well tolerated and there were no clinical notable abnormalities in ECG recordings, vital signs or laboratory tests. Three subjects (13%) reported five adverse events. A transient (
ISSN:0312-5963