None listed
Conditions
Interventions
Intervention1: Ustekinumab 45mg/0.5 ml injection, Auto-injector (AI): Dosage Form: injection, Auto-injector (AI)
Strength(s): 45 mg/ 0.5 mL
Dose: 45 mg/0.5 mL
Manufacturer: Accord Healthcare Ltd., UK
Sponsors
Intas Pharmaceuticals Ltd
Lambda Therapeutic Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Non-smoking, normal, healthy, adult, human male volunteers between 18 and 45 years of age (both inclusive). 2) Having body weight greater than or equal to 50 kg and less than or equal to 85kg, and body mass index (BMI) between 18.5 and 29.9 (both inclusive), calculated as weight in kg/height in meter2. Stratification will be done based on weight to less than or equal to 70 kg and greater than 70 kg. 3) Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P A view) recordings. 4) Subject with C-reactive protein less than or equal to 1.5 into upper limit of normal (ULN). 5) Subject had adequate liver function as determined by the following results: Serum alanine aminotransferase and aspartate aminotransferase less than or equal to 1.5 into ULN. Total bilirubin less than or equal to 1.5 into ULN. 6) Able to understand and comply with the study procedures, in the opinion of the investigator. 7) Able to give voluntary written informed consent for participation in the study. 8) Subjects should not receive a BCG vaccine within 1 year before dosing and agree to not take it during the study and at least 1 year after dosing. 9) Subjects will agree not to receive live vaccination (except the COVID-19 vaccine) during the study. 10) Subject will agree not to donate blood plasma platelets during the study and at least 3 months after the end of study. 11) Subjects will agree to use effective contraception (e.g. Double barrier method) during sexual intercourse during the study and for at least 90 days after end of study. 12) Subjects who agree to refrain from donation of sperm from check-in until 90 days after the end of study.
Exclusion criteria
Exclusion criteria: a) Known hypersensitivity or idiosyncratic reaction to Ustekinumab or any excipients or any related drug or any substance (specifically any biologic product or the constituents of Ustekinumab). b) Known hypersensitivity to host cell [murine myeloma cell or Chinese hamster ovary cells] derived proteins, latex, food, or other substance. c) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system. d) Use or intend to use any medications products known to alter drug absorption, metabolism, or elimination processes, including St. John s wort, within 30 days prior to dosing. e) Use or intend to use any prescription medications products or other acceptable concomitant Medications within 30 days prior to dosing or slow-release medications products considered to be still active within 14 days prior to dosing. f) Use or intend to use any nonprescription medications products including vitamins, minerals, and phytotherapeutic herbal plant-derived preparations (other than St. John s wort) within 7 days prior to dosing. g) Use of COVID-19 vaccine from 4 weeks prior to dosing; In any such case subject selection will be at the discretion of the Principal Investigator. h) Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs induced urticaria. i) A recent history of harmful use of alcohol (less than 2 years), i.e., alcohol consumption of more than 14 standard drinks per week (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 48 hours prior to dosing. j) History of invasive systemic fungal infections (including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystis, etc.) or other opportunistic infections judged by the investigator, including local fungal infections or a history of herpes zoster. k) History of any malignancy. l) History of systemic or local infection, a known risk of developing sepsis, and or known active inflammatory process or evidence of an infection requiring inpatient hospitalisation or intravenous (IV) antibiotics less than or equal to 24 weeks prior to the administration of the study drug (day 1) m) Smokers, or who have smoked within the last six months prior to the start of the study. n) The presence of clinically significant abnormal laboratory values during screening. o) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. p) History or presence of seizure or psychiatric disorders. q) A history of difficulty with donating blood. r) Donation of blood (1 unit or 350 mL) or plasma platelets in the last 90 days prior to screening until 3 months after the end of study visit. s) Participation in a clinical study involving the administration of an investigational drug in the past 90 days or 5 half-lives (whichever is longer), prior to dosing. If an investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, the subject can be included considering 5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish PK equivalence between single subcutaneous (SC) injection (45 mg) of Ustekinumab -Autoinjector in Comparison with SC injection (45 mg) of Ustekinumab -Prefilled syringe.Timepoint: 0.000 (Pre-dose), 12.000, 24.000, 48.000, 72.000, 96.000, 120.000, 144.000, 168.000, 192.000, 216.000, 240.000, 264.000, 288.000, 312.000, 336.000, 480.000, 672.000, 840.000, 1008.000, 1176.000, 1344.000, 1512.000, 1680.000, 2016.000 and 2496.000 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Ustekinumab -Autoinjector after Single SC (45 mg) injection in Comparison with SC injection (45 mg) of Ustekinumab -Prefilled syringe. Any device related complaintsTimepoint: 0.000 (Pre-dose), 12.000, 24.000, 48.000, 72.000, 96.000, 120.000, 144.000, 168.000, 192.000, 216.000, 240.000, 264.000, 288.000, 312.000, 336.000, 480.000, 672.000, 840.000, 1008.000, 1176.000, 1344.000, 1512.000, 1680.000, 2016.000 and 2496.000 hours. | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed