ACTRN12616000138482终止1 期
A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study of Itolizumab (Bmab 600) Administered Subcutaneously and a Randomized, Partial Blind, Placebo-controlled, Comparative Pharmacokinetic and Safety Study of Two Formulations of Itolizumab Administered Intravenously and a Bioavailability Assessment of Subcutaneous Administration of Itolizumab (Bmab 600) in Normal Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 74
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. Male or female between 18 and 50 years of age (inclusive).
- •2. Healthy with no clinically significant medical problems.
- •3. BMI between 18 to 30 kg/m2 with weight between 50 to 100 kg (both inclusive).
- •4. No history of alcohol or drug abuse (Paracetamol, Barbiturates, Benzodiazepines, Cocaine, Methadone, Amphetamines, Methamphetamines, Opiates, Phencyclidine, Tetrahydrocannabinol (cannabis), Tricyclic Antidepressants). Subjects should be enrolled only after passing the urine drug screen (positive test for paracetamol will be allowed).
- •5. Non smokers or light smokers (Less than 5 cigarettes per day) by history and planned during study.
- •6. No history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis.
- •7. No prior exposure to Itolizumab or other biologicals including monoclonal antibodies, fusion proteins etc.
- •8. Willing and able to sign written, informed consent.
排除标准
- •1. Any significant past or current cardiac, pulmonary, hepatic, renal or other medical condition which in the opinion of the investigator would make participation of the subject in this study medically unsafe or compromise the accuracy of assessment of safety, pharmacokinetic and pharmacodynamic data of the study.
- •2. Subjects who have abnormal safety labs outside the local lab ranges will be excluded as per PI's discretion based on his/her assessment of clinical significance.
- •3. Subjects with past medical history of malignancy except basal cell or squamous cell carcinoma of the skin who have had curative surgical treatment and at least 6 months has elapsed since the procedure.
- •4. A value outside the specified range of 90 mm Hg – 140 mm Hg for systolic blood pressure and 50 mm Hg – 90 mm Hg for diastolic blood pressure (both inclusive) at screening.
- •5. Subjects who show a positive Quantiferon TB test for tuberculosis will be excluded. Subjects with history of tuberculosis will be excluded irrespective of prior successful treatment.
- •6. History of clinically significant acute bacterial, viral, or fungal systemic infections in the last 4 weeks prior to screening.
- •7. Clinical or laboratory evidence of an active infection at the time of screening.
- •8. Serological evidence of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screening.
- •9. Vaccination within 3 months of screening for the study or requiring vaccination during the study or within 3 months after completion of the study.
- •10. Females who are pregnant or nursing.
- •11. Females of childbearing potential (i.e., any woman who is not surgically sterile e.g., hysterectomy, bilateral oophorectomy or more than 2 years post menopause) and all men who, if participating in heterosexual sexual activity that could lead to pregnancy are unable or unwilling to practice medically effective contraception during the study. They should agree to use two reliable methods of contraception (e.g., double-barrier condom plus diaphragm, condom or diaphragm plus stable dose of hormonal contraception) throughout the study period and until 3 months after receiving study drug. Women of childbearing potential will require compulsory pregnancy testing. A negative pregnancy test (serum and urine) will be documented during screening and at Day -1 respectively.
- •12. Participation in any other drug study within 8 weeks or 5 half lives of the study drug whichever is longer.
- •13. Unable or unwilling to comply with the protocol requirements for study visits and procedures.
- •14. Subjects who do not have good venous access for infusion of study drug or for blood sampling.
- •15. History of hypersensitivity to diphenhydramine or paracetamol.
研究者
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