Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX

FBL-MTX is available as sterile liposomal dispersion for injection at nominal dose strength of 1 mg/mL of methotrexate free base. The dose of 0.1 mg was selected as starting dose in the present study. Three subsequent FBL-MTX dose levels are pre-planned: 0.33 mg, 1 mg and 2.5 mg.

Placebo will consist of sterile saline 0.9% NaCl solution.