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

NCT06494345
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Phase
Phase 1
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Recruitment status
Completed
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Participants
180
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Lead sponsor
AO GENERIUM
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Start date
2023-01-15
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Number of sites
1
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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
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Short title
A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers
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Official title
An Open-label Randomized Comparative Study in Parallel Groups of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Genolair as Solution and Lyophilisate Forms and Xolair® in a Solution Form
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2024-06-09
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First posted
2024-07-10
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Registry last updated
2024-07-10
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Primary completion date
2024-06-09
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Start date
2023-01-15
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Actual participants
180
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Participants
180
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Participant count basis
Actual
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AO GENERIUM
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06494345
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ClinicalTrials.gov ID
NCT06494345
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Other
Masking
No masking
Sources for study design
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  1. Pharmacokinetics: Peak Plasma Concentration (Cmax)

    Timeframe: Day 85

    Analysis of equivalence of Cmax

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

    Timeframe: Day 85

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

  1. Proportion of participants with Adverse Events (AE)

    Timeframe: Day 85

    The Investigator will carefully monitor each subject throughout the study for any adverse events (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \[MedDRA\])

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

    Timeframe: 2016 hours

    Time-points: 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

Sources for outcomes
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Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
Yes

  • 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.

  • 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.
  • Positive test for the presence of alcohol in exhaled air.
  • Smoking more than 5 cigarettes per day for 3 months before signing the informed consent.
  • Drug dependence and a positive urine test for the use of prohibited drugs and substances.
  • Positive test results for hepatitis B and/or C, HIV, or syphilis.
  • Unwillingness or inability to comply with the recommendations prescribed by this protocol.
  • Any planned surgical intervention during the study period.
  • Reluctance to comply with contraceptive methods.
Sources for eligibility
clinicaltrials.gov

  • State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"Moscow, Russia
Sources for sites
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Related records

Drugs (4)

Lead sponsors (1)

Conditions (5)

Targets (2)