Allergy MedDRA version: 9.1 Level: LLT Classification code 10001738 Term: Allergy
Conditions
Interventions
Product Name: RP 01
Pharmaceutical Form: Solution for injection
Current Sponsor code: RES 08
Other descriptive name: OSO
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Con
Sponsors
Resistentia Pharmaceuticals AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male patient aged between 18 and 60 years, inclusive. 2. Allergy to at least one of the following aero allergens; cat, dog, horse, timothy grass, birch, mugwort, house dust mite and cladosporium herbarum, verified by an elevated specific IgE level (=0,50 kU/l IgE; ImmunoCAP®). 3. Mentally competent with the ability to understand and comply with the requirement of the study 4. Signed informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Allergies and Respiratory tract conditions 1. Diagnosis of asthma. 2. Prior experience of an anaphylactic reaction. Concomitant medication 3. Use of systemic corticosteroids within 2 months prior to randomisation. 4. Corticosteroids used for inhalation within 1 month prior to randomisation. 5. Use of any antibiotics within 1 month prior to randomisation. 6. Immunosuppressive treatment received within 1 month prior to randomisation. 7. Treatment with omalizumab (Xolair) within 1 year prior to randomization. 8. Allergy vaccination therapy (desensitisation immunotherapy) within 10 years prior to randomization. 9. Any other vaccination received within 3 months prior to randomisation or scheduled to receive vaccination during the first 20 weeks of the study. Other medical history 10. History or evidence of significant cardiovascular, renal, hepatic or endocrine disease 11. Other clinical significant findings regarding health status as judged by medical history, physical examination, ECG, vital signs, clinical chemistry/hematology/urinalysis that may interfere with the study treatment. 12. Positive test for human immunodeficiency virus (HIV), Hepatitis B surface antigen tests and/or antibodies to Hepatitis C virus. (The patient should have been tested within 3 months prior to randomization.) Other 13. Treatment with an investigational drug within 2 months prior to randomization 14. Current alcohol or drug abuse 15. Donation of blood, exceeding 450 ml, during the 3 months prior to the first administration of the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective is to compare two different formulations of RP 01 in terms of safety, tolerability and efficacy. This will be assessed by adverse events (AEs), laboratory safety variables, expression of FceRI on blood basophiles and the specific immune response markers IgG anti-IgE and IgG anti-OSO.;Main Objective: The primary objective is to establish the maximum tolerable effective dose of RP 01 as an anti-IgE immunotherapy in allergic patients. Adverse events (AEs), laboratory safety variables and the specific immune response markers IgG anti-IgE and IgG anti-OSO will be assessed. ;Primary end point(s): Efficacy assessments included in the study are based on various specific immune response markers: - Induction of IgG anti-OSO antibodies and IgG anti-IgE antibodies. - Expression of FceRI on blood basophils. - Induction of IgE neutralizing antibodies - Levels of total IgE and free IgE. - Basophil activation. Bullets 3-5 represents exploratory variables. | — |
Countries
Sweden
Outcome results
None listed