A glycosylated recombinant human granulocyte colony stimulating factor produced in a novel protein production system (AVI-014) in healthy subjects: a first-in human, single dose, controlled study

AVI-014 is an egg white-derived, recombinant, human granulocyte colony-stimulating factor (G-CSF). This healthy volunteer study is the first human investigation of AVI-014. 24 male and female subjects received a single subcutaneous injection of AVI-014 at 4 or 8 mcg/kg. 16 control subjects received...

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Veröffentlicht in:	BMC clinical pharmacology 2009-01, Vol.9 (2), p.2-2, Article 2
Hauptverfasser:	Varki, Roslyn, Pequignot, Ed, Leavitt, Mark C, Ferber, Andres, Kraft, Walter K
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Antibody Formation Dosage and administration Dose-Response Relationship, Drug Double-Blind Method Drugs Female Filgrastim Granulocyte colony-stimulating factor Granulocyte Colony-Stimulating Factor - administration & dosage Granulocyte Colony-Stimulating Factor - adverse effects Granulocyte Colony-Stimulating Factor - immunology Granulocyte Colony-Stimulating Factor - pharmacokinetics Granulocyte Colony-Stimulating Factor - pharmacology Health aspects Humans Injections, Subcutaneous Leukocyte Count Male Middle Aged Neutrophils - chemistry Neutrophils - drug effects Pharmacokinetics Properties Recombinant Proteins Therapeutic Equivalency
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