CTRI/2022/01/039850已完成1 期
A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 127
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
入选标准
- •1. Healthy male and female volunteers, 18 to 50 years of age at the time of signing informed consent.2. In general good health as determined by a qualified physician based on a comprehensive medical history, physical examination including vital signs, laboratory haematology, clinical chemistry, urinalysis and 12-lead ECG during screening.3. Body mass index (BMI) between 18.5 and 30.0 kg/m2 and body weight between 50 and 100 kg (both inclusive). 4. Screening parameters (vital signs, physical examination, clinical laboratory tests, 12-lead ECG, chest x-ray, thyroid function etc.) are within the normal range or if outside the normal range, assessed as clinically nonsignificant by the Investigator (unless the value constitutes an explicit exclusion criterion).5. Male volunteers must be willing to abstain from sexual intercourse, sperm donation or willing to use in all relationships with a partner from the opposite sex a condom for the male partner and another effective method of contraception (such as an intra-uterine device, vaginal ring, oral contraceptive, injectable progesterone, or sub-dermal implant) for the female partner from the time of dosing until 3 months after the last dosing date, unless one of the partners is medically confirmed to be either infertile or surgically sterile.6. Female volunteers should be either post menopausal or surgically sterile Note: (ââ?¬Å?Postmenopausalââ?¬? is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/ml, or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy).7. Capable, and amenable, to provide written informed consent to the study requirements.8. Willing to abide by study restrictions for the entire study duration.
排除标准
- •1. Positive test result for Quantiferon-TB Gold test, syphilis, hepatitis B, hepatitis C, or HIV-1 or 2.
- •2. Any prior exposure to tocilizumab or to any other agent directly acting on interleukin-6 or on its receptors including investigational products (e.g. siltuximab, sarilumab etc.).
- •3. Live virus vaccination within 3 months prior to screening or intention to receive live virus vaccination during the trial or up to 3 months after the administration of the study drug.
- •4. Administration of immunoglobulins for anti-tetanus and antirabies post-exposure prophylaxis within 3 weeks prior to administration of study
- •5. History of immunodeficiency or other clinically significant immunological disorders, or auto-immune disorders, ongoing or frequent/ recurring
- •infection defined as more than 3 per year requiring treatment or prior herpes zoster not fully healed (including the post-herpetic neuralgia period if occurring) within one year prior to randomization or history of systemic
- •fungal infection at any time.
- •6. Allergy, or hypersensitivity, to any recombinant human, or humanized antibodies, other therapeutic proteins, or any excipients in the study formulations.
- •7. Current manifestations of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma including childhood asthma currently showing clinical manifestations, urticaria, angioedema, eczematous dermatitis), hypersensitivity, or allergic reactions.
- •8. Non-suitable skin for dosing or post-dosing evaluations in the upper arm (same arm to be used as the injection site in the both periods) for any
- •reasons (including presence of tattoos, skin pigmentation disorders, scarring etc., which may obscure the injection site).
- •9. Blood donation, participation in any study requiring repeated blood sampling or hemorrhage requiring treatment, or any transfusion in the past 3 months.
- •10. Screening blood pressure higher than 140 mm Hg (systolic), or higher than 90 mm Hg (diastolic), or volunteers currently on anti-hypertensive drugs. Up to two repeats on same or different days are allowed and, in this case, the mean of the measurements will be used to decide on eligibility. Screening blood pressure is to be measured in the sitting position after 5 minutes rest.
- •11. History of relevant orthostatic hypotension, fainting spells, or blackouts deemed in the opinion of the Investigator to pose clinical risk to the subjects.
- •12. QTc (Fridericia correction) longer than 450 milliseconds or other clinically relevant ECG abnormalities such as atrial fibrillation, atrial flutter, Wolf-Parkinson-White syndrome, or presence of a cardiac pacemaker.
- •13. History or presence of any clinically relevant nervous system disease including, but not restricted to any stroke/TIA (Transient Ischemic Attack), or of seizures other than febrile seizures, before the age of 5 years.
- •14. History of and/or current gastrointestinal, renal endocrine, pulmonary, hepatic, cardiovascular (including history of or presence of angina, exertional dyspnea, orthopnea, congestive heart failure or myocardial infarction and thrombotic or embolic episode requiring treatment, hematological (including pancytopenia, aplastic anemia or blood dyscrasia and coagulopathies, or an INR higher than 1.5), metabolic (including known diabetes mellitus) considered as significant by the Investigator.
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