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

✍ Scribed by V. Chaudhry; M. Giuliani; B.G. Petty; D. Lee; M. Seyedsadr; D. Hilt; D.R. Cornblath

• Book ID: 101255524
• Publisher: John Wiley and Sons
• Year: 2000
• Tongue: English
• Weight: 105 KB
• Volume: 23
• Category: Article
• ISSN: 0148-639X
• DOI: 10.1002/(sici)1097-4598(200002)23:2<189::aid-mus7>3.0.co;2-8

✦ Synopsis

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 µg/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.