ACTRN12624001043527尚未招募1 期
A phase 1, randomised, double-blind, placebo-controlled, single-dose and multi-dose escalation study to investigate the safety, tolerability and pharmacodynamics of subcutaneously administered proinsulin peptide/calcitriol liposomes (ASITI-201) in stage 3 Type 1 Diabetes.
niQuest Pty Ltd0 个研究点目标入组 36 人开始时间: 2024年8月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
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 45 Years（—）
- 性别
- All
入选标准
- •1.Adults who meet the American Diabetes Association T1D criteria; Female of child-bearing potential must agree to use two effective forms of contraception from enrolment to completion of the study
- •2.Diagnosis of T1D within 5 years of enrolment;
- •3.Positive for at least one diabetes-related autoantibody, including but not limited to: Glutamate decarboxylase-65 (GAD-65); Insulin, if obtained within 10 days of the onset of exogenous insulin therapy; Insulinoma antigen-2 (IA-2); or Zinc transporter-8 (ZnT8);
- •4.Random C-peptide >0.2 nmol/L or MMTT-stimulated mean C-peptide AUC of >0.2 nmol/L;
- •5.Positive for HLA-DQB1*03:02 or HLA-DQB1*02:01;
- •6.Written informed consent;
- •7.Agree to forego vaccinations during the first 4 weeks of the study.
排除标准
- •1.Latent autoimmune diabetes of adults (LADA)
- •2.History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, liver or gastrointestinal disease.
- •3.An active inflammatory disease other than T1D with the exception of stable thyroid or celiac disease;
- •4.Current or prior treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status e.g. including Teplizumab, TNF inhibitors or JAK inhibitors.
- •5.Current use of drugs other than insulin to treat hyperglycaemia (e.g. metformin, sulfonylureas, glinides, thiazolidinedione, GLP1 agonists, SGLT2 inhibitors, DPP-IV inhibitors, or amylin).
- •6.Current use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin, systemic glucocorticoids, beta blockers).
- •7.Serious infection requiring hospitalisation within last 28 days;
- •8.Receipt of any live attenuated vaccines within 4 weeks prior to entry;
- •9.Major surgery within last 28 days;
- •10.CBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT greater than 1.5 x out of normal laboratory ranges at entry
- •11.Positive serology for HIV, or infection with HBV or HCV;
- •12.Any known or suspected allergies to the study drug or its constituents or a history of severe allergy or anaphylaxis;
- •13.Inadequate venous access to allow collection of blood samples;
- •14.History of drug or alcohol abuse;
- •15.Participation in any other clinical trial of an investigational medical product or device within 30 days or 5 half-lives before study start, whichever comes later;
- •16.If, in the opinion of the PI, the participant appears not to be able to perform the needed responsibilities of participation in the clinical study.
研究者
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