A Phase I, randomized, double-blind, three-group study in healthy participants to evaluate if there is similarity between the amount of study drug in the bloodstream after dosing, the safety of the study drug, any side effects that might be associated with it and laboratory tests of participants’ blood after receiving either Bmab 1200, US Stelara or EU Stelara and to evaluate how the immune system may interact with these drugs
- Conditions
- Moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitisNot ApplicablePsoriasis vulgaris, Crohn disease, Ulcerative colitis
- Registration Number
- ISRCTN11424009
- Lead Sponsor
- Biocon (India)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 258
1. Males or females, between 18 and 55 years of age, inclusive
2. For Japanese subjects only:
2.1. Must have Japanese parents and Japanese grandparents
2.2. Must not have lived outside Japan for >10 years
3. Body weight between 60.0 and 100.0 kg; however, for Japanese subjects, permissible body weight range will be between 55.0 and 100.0 kg
4. Body mass index between 18.0 and 30.0 kg/m², inclusive
5. In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia [e.g., suspicion of Gilbert’s syndrome based on total and direct bilirubin] is acceptable) at screening, check-in, and predose on Day 1 (where applicable) and from the physical examination at screening or check-in, as assessed by the investigator (or designee).
6. Females will not be pregnant (as confirmed by pregnancy testing at screening and check-in) or lactating, and females of childbearing potential and males will agree to use contraception
7. Should be a nonsmoker or light smoker, i.e smokes a maximum of five cigarettes (or three cigars or three pipe-full) or equivalent for e-cigarettes (10 puffs of an e-cigarette is considered equivalent to one combustible cigarette), or other tobacco- or nicotine-containing product per day; and ability and willingness to refrain from smoking from check-in until Day 2 and to limit smoking to five cigarettes per day from Day 3 through the end of study visit
8. Able to comprehend and willing to sign an ICF and abide by the study restrictions
1. Significant history or clinical manifestation of malignancy, or any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, lymphatic disorder, immune system disorder, musculoskeletal, connective tissue, or psychiatric disorder, as determined by the investigator (or designee)
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound (specifically any biologic product or the constituents of Stelara, Bmab 1200, or hypersensitivity to host cell [murine myeloma cell or Chinese hamster ovary cells]derived proteins, latex), food, or other substance, unless approved by the investigator (or designee)
3. Positive hepatitis B or C panel and/or positive human immunodeficiency virus test
4. Any current active infections, including significant localized infections (eg, middle ear infections or ophthalmic infections), or any recent history (within 1 week prior to study drug administration) of active infections, cough or fever, or a history of recurrent or chronic infections
5. History of active tuberculosis (TB) or presence of active or latent TB. Positive result for QuantiFERON TB-Gold test at screening. Having resided or travelled in regions where TB and mycosis are endemic within 90 days before screening, or who intend to visit such a region during the period of 90 days after dosing.
6. Historical or planned major surgery within 12 weeks of dosing and during the study
7. Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing or have the intention of receiving the COVID-19 vaccine within 14 days postdose
8. Received any vaccine within 4 weeks before screening or have the intention to receive a vaccination (with the exception of the COVID-19 vaccine) during the study. Subjects who have had Bacillus Calmette–Guérin (BCG) vaccination within 1 year prior to dosing. Subjects must agree not to receive a BCG vaccination during the study and through at least 1 year after dosing
9. 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
10. Use or intend to use any prescription medications/products other than hormone replacement therapy (estrogen and progestogen), oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing or slow-release medications/products considered to still be active within 14 days prior to check-in
11. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations (other than St John’s wort, which has been previously defined) within 7 days prior to check-in
12. Participation in a clinical study involving administration of an investigational drug(new chemical entity) in the past 90 days or 5 half-lives (whichever is longer), prior to dosing
13. Known history of previous exposure to ustekinumab or ustekinumab biosimilar, or any IL-12 or IL-23 monoclonal antibodies, approved or investigational
14. Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals ½ pint (285 ml) of beer or lager, one glass (125 ml) of wine, or 1/6 gill (25 ml) of spirits.
15. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat)at screening or check-in
16. History of a
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC0-inf and Cmax of the study drug following a single 45 mg subcutaneous injection. These will be calculated based on the PK blood samples. Sampling timepoints within 60 minutes predose and 12 hours postdose on Day 1, and on Days 2 (24 hours postdose), 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 21, 29, 36, 43, 50, 57, 64, 71, 85, and 113. PK will be measured by a validated PK method
- Secondary Outcome Measures
Name Time Method