None listed
Conditions
Interventions
Intervention1: Omalizumab (r-DNA origin) injection 150 mg/ml: Kashiv Bioscience LLC, USA
Control Intervention1: XOLAIR�®(omalizumab) injection
: Reference product of Genentech, Inc., A Member of the
Sponsors
Kashiv BioSciences LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to dosing), 18 - 65 years of age (inclusive), with body mass index (BMI) greater than and equal to 19 and less than and equal to 26 kg per m2, and body weight not less than 45 kg or greater than 90 kg at the time of screening. 2. Subject should be having serum IgE less than 100 IU per ml at the time of screening 3. Healthy as defined by: o The absence of clinically significant (in the opinion of the PI or designee) illness or surgery within 4 weeks prior to dosing. o The absence of febrile (defined by a documented body temperature of 101.5 �°F or greater) or infectious illness within 1 week prior to dosing. 4. Have a normal 12-lead ECG or one with abnormality considered clinically insignificant. 5. Have a normal chest X-ray (P. A. view). 6. Have acceptable range of SpO2 concentration (95 percent - 100 percent ) 7. Females of childbearing potential must be willing to use acceptable contraceptive methods throughout the study, and for 30 days thereafter. 8. Females of non-childbearing potential must have undergone sterilization procedures, at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status during screening. 9. Capable of providing written informed consent. 10. Male subjects willing to follow approved birth control method for the duration of the study, and for 30 days thereafter, such as (a double barrier method) vasectomy, condom with spermicide, condom with diaphragm or abstinence, subject should also not donate sperm during this time.
Exclusion criteria
Exclusion criteria: 1. Participation in a clinical trial involving the administration of an investigational drug or marketed drug within 90 days prior to initial dosing (90 days for any biologics) or concomitant participation in an investigational study involving no drug administration. 2. History of parasitic infection. 3. Routine doses of the following medications within 60 days prior to screening: oral or parentral corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide. 4. History of Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 90 days prior to screening. 5. Subjects with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except nonmelanoma skin cancer that has been treated or excised and is considered resolved. 6. Hypersensitivity to omalizumab or any component of the formulation. 7. History of anaphylactic shock. 8. History of being on allergy vaccine therapy 9. Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the subjects. 10. Positive test for hepatitis B, hepatitis C, or HIV. 11. Illicit drug use as evidenced by a positive test for urine drug screen at screening or check -in. 12. Positive result for urine alcohol test at screening or check-in 13. Females with positive pregnancy tests at screening or check-in. 14. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or completing follow-up activities. 15. Vital sign abnormalities at screening. 16. History of significant alcohol abuse within one year prior to initial dosing or regular use of alcohol (more than 14 units of alcohol per week) within six months prior to initial dosing. 17. History of drug abuse or use of illicit/illegal drugs within 1 year prior to initial dosing. 18. Donation of plasma within 90s days of dosing; blood donation or significant loss of blood within 90 days of dosing. 19. Females who are breast-feeding or lactating. 20. Subjects who are on a special diet or who have self-reported a weight loss of more than 15 pounds within 1 month prior to initial dosing at Day 1. 21. History of any surgical or medical conditions that could have significantly altered the absorption, distribution, metabolism or excretion of any drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the pharmacokinetics (PK) of the Test product Vs. US-LICENSED XOLAIR and Test product Vs. EUAPPROVED XOLAIR following single subcutaneous dose. To compare the pharmacodynamics (PD) of the Test product Vs. US-LICENSED XOLAIR and Test product Vs. EUAPPROVED XOLAIR following single subcutaneous dose. Timepoint: For PK Analysis: Pre dose (within 30 minutes prior to dosing) on Day 1; at 3.00, 6.00 and 12.00 hours post dose on Day1 and thereafter 24.00 (day 2), 48.00 (day 3), 144.00 (day 7), 312.00 (day 14), 480.00 (day 21), 984.00 (day 42), 1320.00 (day 56), 1656.00 (day 70), 2328.00 (day 98) and 3000.00 (day 126) hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate immunogenicity by comparing rate of ADA (antidrug antibody) between Test Product Vs. US-LICENSED XOLAIR and Test product Vs. EU-APPROVED XOLAIR following single subcutaneous dose. To assess the safety and tolerability of the Test product.Timepoint: ADA samples for anti-omalizumab antibody: Five blood samples will be collected during the entire study | — |
Countries
India
Contacts
Public ContactDr Prayag Shah
Kashiv Biosciences Pvt. Ltd.
Outcome results
None listed