EUCTR2019-003459-12-DE进行中（未招募）1 期
A Single-blind, Placebo-controlled, Single-center Study Investigating the Dose of Human Anti-Human Platelet Antigen (HPA)-1a Immune Globulin (NAITgam) Needed to Eliminate HPA-1a Positive Platelets Transfused to HPA-1a Negative Healthy Male Volunteers
Rallybio, IPA, LLC0 个研究点目标入组 28 人开始时间: 2020年3月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- •2. Healthy male participants, = 18 and = 65 years of age
- •3. Body mass index (BMI) < 35 kg/m2
- •4. HPA-1a negative
- •5. Cohorts 1, 1B and 2 only: HLA-A2 negative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of hypersensitivity to platelet concentrates or human plasma proteins
- •2. IgA levels < 0.06 g/L
- •3. Blood donation received within 3 weeks of screening
- •4. Platelet counts < 150 x 109/L or > 450 x 109/L
- •5. Any type of known platelet function disorder
- •6. Treatment with NSAIDs (eg, acetylsalicylic acid) or selective serotonin reuptake inhibitors within 7 days prior to screening
- •7. Chronic or ongoing active infectious disease requiring systemic treatment including, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, and tuberculosis
- •8. Individuals with increased risk of thrombotic events (eg, history of pulmonary embolism or thrombosis)
- •9. Current participation in any other interventional clinical study (or within 90 days prior to screening)
- •10. Participants known or suspected of not being able to comply with this study protocol (eg, due to alcoholism, drug dependency, or psychological disorder)
- •11. Presence of HLA class I-antibodies at screening – for participants, not previously transfused, this is defined as MFI value > 3,000 on the One-Lambda’s LABScreen Single Antigen assay
- •12. Ongoing active infection with HIV and/or hepatitis B and/or C virus
- •13. Vaccination received within 1 month of screening
- •14. Current diagnosis of diabetes mellitus or increased HbA1c at screening
研究者
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