Tolerability of recombinant-methionyl human neurotrophin-3 (r-metHuNT3) inhealthy subjects

This phase I, double-blind, randomized, placebo-controlled study evaluated the safety of single and multiple (daily for 7 days) subcutaneous administr ations of recombinant-methionyl human neurotrophin-3 (r-metHuNT3) in health y human volunteers at seven doses, ranging from 3 to 500 mu g/kg/day. No se rious or life-threatening adverse events occurred. The most frequently reco rded adverse effects were mild injection-site pain, diarrhea, and elevation of liver function tests. No change in neurologic function was noted with t hese dosing regimens. We conclude that r-metHuNT3 is safe and well tolerate d in the dosages used in this study. (C) 2000 John Wiley & Sons, Inc.