Document Detail


Tolerability of recombinant-methionyl human neurotrophin-3 (r-metHuNT3) in healthy subjects.
MedLine Citation:
PMID:  10639609     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
V Chaudhry; M Giuliani; B G Petty; D Lee; M Seyedsadr; D Hilt; D R Cornblath
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Muscle & nerve     Volume:  23     ISSN:  0148-639X     ISO Abbreviation:  Muscle Nerve     Publication Date:  2000 Feb 
Date Detail:
Created Date:  2000-02-10     Completed Date:  2000-02-10     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  7803146     Medline TA:  Muscle Nerve     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  189-92     Citation Subset:  IM    
Copyright Information:
Copyright 2000 John Wiley & Sons, Inc.
Affiliation:
Department of Neurology, Meyer 6-119, The Johns Hopkins Hospital, Baltimore, Maryland 21287, USA. vchaudh@jhmi.edu
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MeSH Terms
Descriptor/Qualifier:
Adult
Brain-Derived Neurotrophic Factor / administration & dosage,  pharmacokinetics,  toxicity*
Diarrhea / chemically induced
Double-Blind Method
Female
Humans
Injections, Subcutaneous
Liver Function Tests
Male
Neurotrophin 3 / administration & dosage,  pharmacokinetics,  toxicity*
Pain / chemically induced
Physical Examination
Recombinant Proteins / administration & dosage,  pharmacokinetics,  toxicity
Grant Support
ID/Acronym/Agency:
RR-00052/RR/NCRR NIH HHS; RR00722/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Brain-Derived Neurotrophic Factor; 0/Neurotrophin 3; 0/Recombinant Proteins; 0/r-metHuBDNF protein, recombinant

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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