EUCTR2015-003934-28-GB进行中（未招募）1 期
Enhanced Epidermal Antigen Specific Immunotherapy trial -1 (EE-ASI-1): A Phase 1a study of gold nanoparticles administered intradermally by microneedles to deliver immunotherapy with a proinsulin derived peptide in Type 1 diabetes. - EE-ASI-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4
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
- All
入选标准
- •1.Clinical diagnosis of type 1 diabetes for > 3 months (dated from the first insulin injection).
- •2.Commenced on insulin treatment within 1 month of diagnosis after diagnosis.
- •3.Age 16 to 40 years
- •4.2 hour post-meal UCPCR > 0.53 nmol/mmol on at least one occasion (maximum 3 tests on different days)
- •5.Possession of 0401 allele at the HLA-DRB1 gene locus
- •If female, must be (as documented in patient notes):
- •a.surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrolment), or
- •b.using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrolment, or
- •c.have a sexual partner with non-reversed vasectomy (with confirmed azoospermia), or
- •d.be using 1 barrier method with the use of a spermicide(e.g., condom, diaphragm or cap)
- •e.have placement of a intra-uterine device
- •6.If male, must be:
- •a.using a barrier method of contraception (condom) with the use of a spermicide. or
- •b. have a sexual partner using one of the methods in point 7 above or
- •c.have a non-reversed vasectomy (with confirmed azoospermia),
- •7.Written and witnessed informed consent to participate.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.HbA1c > 86mmol/L (10%).
- •2.Females who are pregnant, breast-feeding or not using adequate forms of contraception.
- •3.Previous diagnosis of renal disease including glomerulonephritis or nephropathy.
- •4.Raised serum creatinine or abnormal urine albumin/creatinine ratio (ACR). If the initial ACR is raised, this should be repeated on two further occasions as first morning samples. The subject can be included if both of these samples are negative (within the reference range).
- •5.Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to receiving the IMP and any monoclonal antibody therapy given for any indication. Note that previous exposure to proinsulin peptide C19-A3 in a clinical trial is not an exclusion criterion.
- •6.Use of any hypoglycaemia agents other than insulin, for more than 6 weeks, at any time prior to trial entry.
- •7.Use of inhaled insulin.
- •8.Known alcohol abuse, drug abuse, HIV or hepatitis.
- •9.Any other medical condition which, in the opinion of investigators, could affect the safety of the subject’s participation or outcomes of the study, including immunocompromised states and autoimmune conditionsor outcomes of the study, including immunocompromised states and autoimmune conditions.
- •10.Subjects should not have had immunisations (flu and others) for 1 month prior to trial entry and should not receive any during their time in the trial
- •11.Recent subject’s involvement in other research studies which, in the opinion of investigators, may adversely affect the safety of the subjects or the results of the study.
研究者
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