None listed
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: MP14 solution for injection 150 mg/mL in pre-filled syringe: Strength 150 mg/mL Solution for injection.
Single Dose of 1 mL (150 mg)
Control Intervention1: Xola
Sponsors
SEPIDEH YAZDIANPOUR
Ms Jeevan Scientific Technology Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adult human subjects 18 to 45 years of age both inclusive and weight 50 and 90 kg BMI 18.5 to 30.0 kg per m including both. Acceptable findings during registration and screening including medical history physical examination laboratory evaluations 12 lead ECG and chest X Ray posteroanterior view. Non smokers and non alcoholic. Values within normal ranges for laboratory parameters upon evaluation by the investigator or physician for any of the following tests. Subject with a total IgE level of 100 IU per mL. Subjects able to communicate effectively. Subjects willing to give written informed consent and adhere to all the requirements of this protocol. Subject willing to abstain from consumption of caffeine and xanthine-containing drinks and products tea coffee chocolate cola etc. energy drinks products containing poppy seeds from 72.00 hours prior to admission until the last post dose blood sample collection in study period. Subject willing to abstain from consumption of citrus fruits including grapefruit and grapefruit juice and cranberries including juices fruit drinks etc. from 7 days before drug administration until the last post dose blood sample collection in study period. Male subjects with female partners of reproductive potential should use effective contraception during the study. Subjects with normal results of Clinical Breast Examination. Postmenopausal for at least 1 year or Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy has been performed on the subject or Female of childbearing potential practicing an acceptable method of birth control for the duration of the study and at least two weeks thereafter as judged by the investigators such as condoms foams jellies diaphragm and intrauterine device IUD or abstinence.
Exclusion criteria
Exclusion criteria: Volunteers having known history of contraindication or hypersensitivity e.g. anaphylaxis to Omalizumab or related group of drugs. History of significant asthma urticaria or other allergic type reactions after taking aspirin or other NSAIDs. History of aggravated allergy hypersensitivity to excipients in study drugs or intolerance to these components. Presence of autoimmune diseases. Acute infectious diseases that ended less than 4 weeks before drug administration. History of seizures diabetes migraine hypertension cardiovascular pulmonary neurological or psychiatric disease or disorder dermatological endocrine immunological hepatic renal hematopoietic gastrointestinal ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician. History of cerebral infarction myocardial infarction and pulmonary embolism. History of gastrointestinal GI inflammation bleeding ulceration and perforation of the stomach small intestine or large intestine. History or evidence of exfoliative dermatitis Stevens Johnson syndrome SJS toxic epidermal necrolysis TEN Angioedema and Bullous Pemphigoid. Any known enzyme inducing or inhibiting drug taken within 14 days before the study. Taking any biological drugs within 3 months or anti IgE biological drugs within 12 months before the study. Participation in a drug research study within 90 days prior to dosing of this study. Blood loss or whole blood donation within 90 days prior to drug administration. Consumption of high caffeine more than 5 cups of coffee or tea per day. History of addiction to any recreational drug or drug dependence. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of study period e.g. fasting due to religious reasons. Intensive exercise and contact sports less than 24 hours before drug administration. Taking biological drugs within 3 months or anti IgE biological drugs within 12 months before the study. History of dehydration from diarrhea vomiting or any other reason within a period of 48.00 hours prior to study admission. Positive results for drugs of abuse benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates in urine during the admission of study period. Positive results for alcohol consumption test breath alcohol or urine alcohol during the admission of study period. History or presence of any bleeding disorder. Difficulty with donating blood. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. Pulse rate less than 70 beats per minute or more than 100 beats per minute. Use of any prescription drugs within 14 days or at least 5 half lives of the compound whichever period is longer prior to study admission. and Use of herbal medicines and any OTC medications including vitamins within 14 days or at least 5 half lives of the compound whichever period is longer prior to study admission History of alcohol abuse and or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to admission of this study. Female subjects demonstrating a positive pregnancy screen. Female volunteer who is pregnant or currently breast feeding. Female vo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate pharmacokinetic similarity of test and reference product in normal, healthy, adult, human subjects under fasting conditions.Timepoint: 00.00, 00.50, 06.00, 12.00, 24.00 (Day 3), 48.00 (Day 4), 72.00 (Day 5), 96.00* (Day 6), 120.00* (Day 7), 168.00* (Day 9), 240.00* (Day 12), 336.00* (Day 16), 504.00* (Day 23), 672.00* (Day 30), 840.00* (Day 37), 1008.00* (Day 44), 1176.00* (Day 51), 1344.00* (Day 58), 1512.00* (Day 65), 1680.00* (Day 72), 1848.00* (Day 79), 2016.00* (Day 86), 2184.00* (Day 93), 2352.00* (Day 100), 2520.00* (Day 107), 2688.00* (Day 114), 2856.00* (Day 121) and 3024.00* (Day 128) hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety & tolerability of single intravenous dose of test & reference product in normal, healthy, adult, human subjects under fasting conditions.Timepoint: Pre-dose, 02.00, 05.00, 11.00, 25.00, 33.00, 49.00, 96.00 (Day 6), 120.00 (Day 7), 168.00 (Day 9), 240.00 (Day 12), 336.00 (Day 16), 504.00 (Day 23), 672.00 (Day 30), 840.00 (Day 37), 1008.00 (Day 44), 1176.00 (Day 51), 1344.00 (Day 58), 1512.00 (Day 65), 1680.00 (Day 72), 1848.00 (Day 79), 2016.00 (Day 86), 2184.00 (Day 93), 2352.00 (Day 100), 2520.00 (Day 107), 2688.00 (Day 114), 2856.00 (Day 121) & 3024.00 (Day 128) hours after dosing & end of the study | — |
Countries
India
Contacts
Public ContactDr Sowmya Bondalapati MD
Jeevan Scientific Technology Ltd
Outcome results
None listed