None listed
Conditions
Interventions
Intervention1: Test Product T: Biosimilar Vedolizumab (INTP 53.1) 108 mg/0.68 mL solution (single
dose) subcutaneous: Dose: 108 mg/0.68 mL solution (single dose)
Route of administration: subcutaneous
Sponsors
Intas Pharmaceuticals Ltd
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Non-smoker, normal, healthy, adult, human subjects greater than or equal to 18 to less than or equal to 45 years of age (both inclusive) 2) Having a body mass index (BMI) between 18.5 and 30.0 (both inclusive), kg per m2 and having a body weight of greater than 50 and less than 90 kg. 3) Not having any significant disease or abnormal findings during screening, medical history, clinical examination, vital sign examination (Radial pulse rate, sitting blood pressure, Respiratory rate and temperature), laboratory evaluations, 12- lead ECG and X-ray chest (PA view; within the last 6 months) recordings. 4) Has the willingness to adhere to the protocol requirements. 5) Capable of communicating effectively with study personnel 6) Able to understand and comply with the study procedures, as per the opinion of the Principal Investigator. 7) Able to give voluntary written informed consent for participation in the trial. 8) In case of Male Subjects: i) Agree to use barrier method (condoms) during the study and even after discontinuation of study till 6 months after the dose of the study. ii) Agree to assure that he will not donate blood or semen anywhere else during the study and for 6 months after the dosing. 9) In case of Female subjects: i) Surgically sterilized at least 6 months prior to study participation; Or If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. And ii) Serum pregnancy test must be negative
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity or idiosyncratic reaction to Vedolizumab or its constituents. 2) History or presence of any disease or disorder known to compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. 3) Significant illness within two (2) weeks prior to dosing or symptoms or signs suggestive of any infection 4) Any clinically significant laboratory finding at the time of screening including i) Hemoglobin level less than 8 g per dL ii) ANC (absolute neutrophil count) less than 1500 per mm3 iii) Platelet less than 1,00,000 per mm3 iv) Liver function test [alanine aminotransferase and aspartate aminotransferase (ALT and AST) greater than or equal to 1.5 into upper limit normal (ULN) and alkaline phosphatase greater than or equal to 1.5 into ULN, total bilirubin greater than or equal to 1.5 mg per dL] v) Renal function test [blood urea nitrogen greater than or equal to 1.5 into institutional normal and creatinine greater than to 1.5 mg per dL] vi) Subject with serum albumin out of laboratory reference range. 5) Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAID-induced urticaria. 6) Previously received any treatment with vedolizumab or related products within 6 months prior to receiving the dose of the study medicine 7) Receipt of an investigational medicinal product or participation in a drug research study within a period of 180 days prior to the dose of study medication. If investigational medicinal product is received within 180 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received 8) Smokers, or who have smoked within last six months prior to start of the study. 9) Ingestion or use of a medicine (prescribed and over the counter (OTC) medication including herbal remedies) at any time within 1 month prior to dosing, use of COVID- 19 vaccine from 14 days prior to dosing, any live vaccine(s) within 3 months prior to dosing; anticoagulant drugs, or anti-platelet drugs within 6 months for prophylaxis and treatment purpose prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator. 10) History of haemoptysis, thrombotic or haemorrhagic events in the past 6 months. 11) Subject with history of hypertension or systolic BP of greater than 140 mmHg and diastolic BP of greater than 90 mmHg at the time of screening (reconfirmed at check-in). 12) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 percentage distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 72 hours prior to receiving study medicine in period I. 13) Use of any recreational drugs or history of drug addiction or testing positive in prestudy drug scans. 14) Donation of blood (1 unit or 350 mL) within 3 months prior to receiving the dose of the st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the pharmacokinetic parameters of biosimilar Vedolizumab (INTP 53.1) of Intas with that of Entyvio (USlicensed product) and Entyvio (EU-licensed product) after single subcutaneous dose in normal healthy, adult, human, subjectsTimepoint: 0.000 hours, 1.000 hours, 2.000 hours, 4.000 hours, 8.000 hours, 16.000 hours, 24.000 hours, 48.000 hours, 72.000 hours, 96.000 hours, 120.000 hours, 144.000 hours, 168.000 hours, 192.000 hours, 240.000 hours, 288.000 hours, 336.000 hours, 408.000 hours, 504.000 hours, 672.000 hours, 840.000 hours, 1080.000 hours, 1344.000 hours, 1680.000 hours, 2016.000 hours, 2352.000 hours, 2688.000 hours and 3024.000 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the immunogenicity of biosimilar Vedolizumab (INTP 53.1) of Intas with that of Entyvio (US-licensed product) & Entyvio (EU-licensed product). To compare the safety & tolerability of biosimilar Vedolizumab (INTP 53.1) of Intas with that of Entyvio (US-licensed product) & Entyvio (EU-licensed product). To compare the pharmacokinetic parameters of Entyvio (USlicensed product) & Entyvio (EU-licensed product).Timepoint: 0.000 hours, 168.000 hours, 336.000 hours, 672.000 hours, 1344.000 hours, 2016.000 hours & 3024.000 hours. | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed