ACTRN12621000663853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
Dr. Reddy’s Laboratories Ltd., Biologics0 个研究点目标入组 300 人开始时间: 2021年6月1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
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
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 non-significant 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: (Postmenopausal” 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 drug.
- •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 manifestation 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 of 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 haemorrhage 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 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 dyspnoea, orthopnoea, 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. This criterion includes any disorder or condition that, in the Investigator’s opinion, may interfere with the safety of the subject, the
研究者
相似试验
已完成
1 期
Comparative Study of 3 Tocilizumab Products in Normal Healthy VolunteeersCTRI/2022/01/039850Dr Reddys Laboratories Ltd127
尚未招募
1 期
Dr. Reddy’s is conducting comparative PK study with DRL_DA (Darbepoetein alfa), reference product (US registered Aranesp®) and reference medicinal product (EU registered Aranesp®) in healthy male volunteersCTRI/2023/09/057697Dr. Reddys Laboratories Ltd.
已完成
1 期
Dr. Reddy’s is conducting comparative PK study with DRL_DA (Darbepoetein alfa) and reference medicinal product (Aranesp®) in healthy male volunteersCTRI/2023/01/049031Dr Reddys Laboratories Ltd48
进行中（未招募）
1 期
Study in Subjects with Asthma to Compare the Bronchodilatoric Effects of Salmeterol (at two different doses) and Fluticasone Propionate when Taken Via a Novel Inhaler Device (PulmoJet®) Compared to the Seretide Diskus® InhalerEUCTR2014-005047-40-BGSanofi-Aventis AG120
进行中（未招募）
1 期
Study in Subjects with Asthma to Compare the Bronchodilatoric Effects of Salmeterol (at two different doses) and Fluticasone Propionate when Taken Via a Novel Inhaler Device (PulmoJet®) Compared to the Seretide Diskus® InhalerMild to moderate asthmaMedDRA version: 17.1Level: LLTClassification code 10003565Term: AsthmaticSystem Organ Class: 100000004855EUCTR2014-005047-40-DESanofi-Aventis AG120