ISRCTN11424009已完成1 期
A Phase I, randomized, double-blind, three-arm, parallel-design study in healthy subjects to evaluate pharmacokinetics, safety, tolerability, and immunogenicity of Bmab 1200 after a single subcutaneous injection in comparison with EU-approved Stelara® and US-licensed Stelara®
Biocon (India)0 个研究点目标入组 258 人开始时间: 2022年4月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
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
- 性别
- All
入选标准
- •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
排除标准
- •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
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