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

Sponsor
AO GENERIUM
Study ID
NCT04601389
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Omalizumab (JSC "GENERIUM", the Russian Federation) — BIOLOGICAL
    150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area
  • Xolair® (Novartis Pharma AG, Switzerland) — BIOLOGICAL
    150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area

Study Details

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

Key Dates

Start date
Apr 18, 2017
Status verified
Oct 2020
Primary completion
Sep 6, 2017
Completion
Sep 6, 2017

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: GNR-044 (JSC "GENERIUM", the Russian Federation)
    150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area
  • Active Comparator: Xolair® (Novartis Pharma AG, Switzerland)
    150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area

Primary Outcome Measure

Assessment of the pharmacokinetic parameter - Tmax [ Time Frame: 5-15 minutes before drug administration, in 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 984, 1344, 1680, 2016 hours after drug administration ]

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