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A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers

NCT06494345 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-07-10

No results posted yet for this study

Summary

This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration) and Xolair® in healthy volunteers

Conditions

  • Allergic Asthma

Interventions

BIOLOGICAL

Genolair, solution for subcutaneous administration, 150 mg

Genolair (omalizumab), solution for subcutaneous administration, 150 mg for single subcutaneous administration

BIOLOGICAL

Genolair, lyophilisate for the preparation of solution for subcutaneous administration

Genolair (omalizumab), lyophilisate for the preparation of solution for subcutaneous administration, 150 mg for single subcutaneous administration

BIOLOGICAL

Xolair®, solution for subcutaneous administration, 150 mg

Xolair® (omalizumab), solution for subcutaneous administration, 150 mg for single subcutaneous administration

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD · JSC GENERIUM

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2024-06-09
Completion
2024-06-09

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 NCT06494345 on ClinicalTrials.gov