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G-CSF Pharmacokinetic Detection Study in Healthy Japanese Adult Males
jRCT1080222641Phase 1Completed
- Sponsor
- Mitsubishi Chemical Group
- Start
- Oct 2014
- Modality
- Cytokines & Interferons → Recombinant Proteins and Enzymes, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 1, open-label trial of lenograstim, efbemalenograstim alfa and recombinant human granulocyte colony-stimulating factor in Severe Congenital Neutropenia Type 7 (SCN7) (3 arms), sponsored by Mitsubishi Chemical Group. Primary endpoints: Detectable period of filgrastim, nartograstim, lenograstim and their metabolites and Changes in blood parameters after G-CSF administration. Started Oct 2014; status: completed.
02
Drugs
lenograstimefbemalenograstim alfarecombinant human granulocyte colony-stimulating factor
03
Conditions
Severe Congenital Neutropenia Type 7 (SCN7)
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