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

NCT04601389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-10-23

No results posted yet for this study

Summary

An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland) after single subcutaneous administration in healthy volunteers at 150 mg

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

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A Markova, MD · Head of the scientific department

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2017-09-06
Completion
2017-09-06

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04601389 on ClinicalTrials.gov