Tolerability of recombinant-methionyl human neurotrophin-3 (r-metHuNT3) in healthy subjects.
This phase I, double-blind, randomized, placebo-controlled study evaluated the safety of single and multiple (daily for 7 days) subcutaneous administrations of recombinant-methionyl human neurotrophin-3 (r-metHuNT3) in healthy human volunteers at seven doses, ranging from 3 to 500 microg/kg/day. No serious or life-threatening adverse events occurred. The most frequently recorded adverse effects were mild injection-site pain, diarrhea, and elevation of liver function tests. No change in neurologic function was noted with these dosing regimens. We conclude that r-metHuNT3 is safe and well tolerated in the dosages used in this study.
Chaudhry
V
V
Department of Neurology, Meyer 6-119, The Johns Hopkins Hospital, Baltimore, Maryland 21287, USA. vchaudh@jhmi.edu
Giuliani
M
M
Petty
B G
BG
Lee
D
D
Seyedsadr
M
M
Hilt
D
D
Cornblath
D R
DR
D000328:Adult; D019208:Brain-Derived Neurotrophic Factor / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000633:toxicity*; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008111:Liver Function Tests; D008297:Male; D020933:Neurotrophin 3 / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000633:toxicity*; D010146:Pain / Q000139:chemically induced; D010808:Physical Examination; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000633:toxicity
D019208:Brain-Derived Neurotrophic Factor; D020933:Neurotrophin 3; D011994:Recombinant Proteins; C109458:r-metHuBDNF protein, recombinant