CTRI/2022/06/043399尚未招募1 期
A RANDOMIZED, DOUBLE BLIND, THREE-ARM, PARALLEL GROUP, SINGLE DOSECOMPARATIVE PK, PD, SAFETY AND IMMUNOGENICITY STUDY COMPARINGADL-018 WITH US-LICENSED XOLAIR AND EU-APPROVED XOLAIRADMINISTERED THROUGH SUBCUTANEOUS ROUTE IN HEALTHY ADULTSUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •o The absence of febrile (defined by a documented body
- •temperature of 101.5 Ã?°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.
排除标准
- •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
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