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