Pharmacokinetics, safety and tolerability of the novel β-hCG derived immunomodulatory compound, EA-230.

ABSTRACT:

Aims

EA-230 is a newly developed synthetic linear tetrapeptide (AQGV) derived from the chorionic gonadotropin hormone (β-hCG). We investigated the pharmacokinetics, safety and tolerability of EA-230 in healthy subjects using different administration strategies.

Methods

Double-blind, randomized, placebo-controlled, dose-escalating phase I studies in healthy subjects using intravenous administration were conducted. In the single dosage study, 32 subjects were assigned to four single dosage groups (1, 3, 10 or 30 mg/kg). In the multiple dosage study, 24 subjects were assigned to three dosage groups (10, 20 or 30 mg/kg, thrice daily for 3 days). In the continuous dosage study, 24 subjects were assigned to three dosage groups (15, 30, or 90 mg/kg/hour for 2 hours). Pharmacokineti

SUBMITTER: van Groenendael R 

PROVIDER: S-EPMC6595371 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature