Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

April 18, 2017

Primary Completion Date

September 6, 2017

Study Completion Date

September 6, 2017

Conditions
Healthy Volunteers
Interventions
BIOLOGICAL

"Omalizumab (JSC GENERIUM, the Russian Federation)"

150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area

BIOLOGICAL

Xolair® (Novartis Pharma AG, Switzerland)

150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area

Trial Locations (2)

115478

"Federal State Budgetary Institution State Scientific Center Institute of Immunology by Federal Medical and Biological Agency of the Russian Federation", Moscow

117556

"State budgetary institution of health care of the city of Moscow City outpatients clinic No. 2 of the Department of Health of the city of Moscow", Moscow

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY

NCT04601389 - Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair® | Biotech Hunter | Biotech Hunter