First-in-Human study of the Safety, Tolerability, Pharmacokinetics and - Preliminary Dynamics of Neuroprotectant 2-Iminobiotin in Healthy Subjects.

CONCLUSION: Single and multiple doses of 2-IB up to 6 doses of 6 mg/kg with and without Captisol® were safe and well tolerated in healthy male subjects. 2-IB proved to be a high-clearance drug with volume of distribution slightly exceeding total body water volume, and with linear PK that appeared not be affected by presence of Captisol®. Sulfobutylether-beta-cyclodextrin (SBECD) in Captisol® had a low-clearance profile with small volume of distribution, with time independent PK. Preliminary PD characterization of repeated iv dosing of 2-IB in an acute peripheral hypoxic ischemia model in healthy subjects did not reveal any notable effects of 2-IB, noting that this model was not selected to guide efficacy in the currently pursued indication of cerebral hypoxia-ischemia. PMID: 31625480 [PubMed - as supplied by publisher]
Source: Current Clinical Pharmacology - Category: Drugs & Pharmacology Authors: Tags: Curr Clin Pharmacol Source Type: research