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

NCT06494345 | Completed Phase 1

• 1 other identifier: OMA-COMP-I
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Omalizumab; Allergic rhinitis; Monoclonal antibody; IgE; Bioequivalence; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Respiratory Hypersensitivity; Immune System Diseases; Anti-Allergic Agents

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Peak Plasma Concentration (Cmax)

  Analysis of equivalence of Cmax

  Day 85

• Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)

  Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity

  Day 85

Secondary Outcomes (2)

• Proportion of participants with Adverse Events (AE)

  Day 85

• Area under the curve "Relative difference in the free IgE concentration compared to the initial value - time"

  2016 hours

Study Arms (3)

Genolair, solution for subcutaneous administration

EXPERIMENTAL

Omalizumab biosimilar

Biological: Genolair, solution for subcutaneous administration, 150 mg

Genolair, lyophilisate for the preparation of solution for subcutaneous administration

ACTIVE COMPARATOR

Omalizumab biosimilar

Biological: Genolair, lyophilisate for the preparation of solution for subcutaneous administration

Xolair®, solution for subcutaneous administration

ACTIVE COMPARATOR

Omalizumab

Biological: Xolair®, solution for subcutaneous administration, 150 mg

Interventions

Genolair, solution for subcutaneous administration, 150 mg BIOLOGICAL

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

Also known as: Omalizumab biosimilar solution

Genolair, solution for subcutaneous administration

Genolair, lyophilisate for the preparation of solution for subcutaneous administration BIOLOGICAL

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

Also known as: Omalizumab biosimilar lyophilisate

Genolair, lyophilisate for the preparation of solution for subcutaneous administration

Xolair®, solution for subcutaneous administration, 150 mg BIOLOGICAL

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

Also known as: Omalizumab solution

Xolair®, solution for subcutaneous administration

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Availability of written informed consent obtained from the volunteer prior to the start of any procedures related to the study;
• Men and women between the ages of 18 and 55 (inclusive) at the time of the Informed Consent Form including those diagnosed with atopic bronchial asthma (BA) and/or allergic rhinitis (AR) of mild severity according to the Investigator's conclusion;
• The absence of clinically significant changes in the volunteers according to the results of a physical examination, including measurement of blood pressure, heart rate, respiratory rate, body temperature, as well as laboratory tests, electrocardiography, and fluorography/chest X-ray;
• Bodyweight from 50 to 90 kg inclusive;
• Body mass index 18.5-30 kg / m2 inclusive;
• Initial concentration of total IgE: ≥30 IU / ml and ≤300 IU / m;
• The volume of forced exhalation in the first second (OFV1) ≥ 80% of the required value;
• Comply with the rules of contraception by the study participants.

You may not qualify if:

• History of use of drugs based on anti-IgE monoclonal antibodies.\*
• Use of drugs based on monoclonal antibodies (in routine practice for therapy and/or as part of a clinical trial) for ≤1 year before signing the informed consent AND/OR single use of drugs based on monoclonal antibodies (in routine practice for therapy and /or as part of a clinical trial) for ≤6 (six) half-lives of the drug before signing the informed consent.
• Use of drugs that affect the pharmacokinetics or pharmacodynamics of the study drugs (use of systemic corticosteroids for ≤30 days before signing the informed consent; use of systemic corticosteroids and monoclonal antibody preparations other than those being studied during the study period; use of immunosuppressive drugs, except for systemic corticosteroids, during the study period and/or use of these drugs for ≤30 days before signing the informed consent; vaccination (with any vaccine) within ≤30 days before signing the informed consent and/or the need for vaccination during the study period; initiation of allergen-specific immunotherapy within ≤3 months before signing the informed consent and/or need for its implementation during the study period).
• A history of an adverse drug reaction to any of the components of the study drug or comparator drugs.
• History of an autoimmune disease.
• A history of a disease associated with the accumulation of immune complexes (including serum sickness).
• The presence of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, hematopoietic, immune systems, which, in the opinion of the Researcher, put the safety of the volunteer at risk when participating in the study, or which will impact on the analysis of safety data if an exacerbation of this disease occurs during the study period.
• Acute infectious diseases less than 4 weeks before signing the informed consent.
• A history of any cancer.
• History of mental illness.
• Donation of blood and its components or blood loss (450 ml of blood or more) less than 3 months before signing the informed consent.
• Participation in clinical trials of drugs less than 3 months before signing the informed consent.
• Special lifestyle (work at night, extreme physical activity).
• Deviations of vital signs: systolic pressure less than 100 mm Hg. Art. or more than 130 mm Hg. Art.; diastolic pressure less than 60 mm Hg. Art. or more than 90 mm Hg. Art.; heart rate less than 60 beats/min or more than 90 beats/min.
• Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of strong alcohol, 100 ml of wine or 250 ml of beer) or anamnestic information about alcoholism, drug addiction, drug abuse.

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (1)

State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"

Moscow, 117556, Russia

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Respiratory Hypersensitivity; Immune System Diseases

Interventions

Solutions; Omalizumab

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Oksana A. Markova, MD

  JSC GENERIUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 10, 2024
• Study Start: January 15, 2023
• Primary Completion: June 9, 2024
• Study Completion: June 9, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)