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Clinical trial

An Open-label, Randomized, in Parallel Groups Comparative Study of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Omalizumab (JSC "GENERIUM", Russia) and Xolair® ("Novartis Pharma AG", Switzerland) After Single-dose Subcutaneous Administration in Healthy Volunteers at 150 mg

NCT04601389 is registered in ClinicalTrials.gov with AO GENERIUM as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-label, Randomized, in Parallel Groups Comparative Study of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Omalizumab (JSC "GENERIUM", Russia) and Xolair® ("Novartis Pharma AG", Switzerland) After Single-dose Subcutaneous Administration in Healthy Volunteers at 150 mg
Lead sponsor
AO GENERIUM
Phase
Phase 1
Overall status
Completed
Start date
April 18, 2017
Completion date
September 6, 2017
Enrollment
84 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

healthy volunteers