NCT04526717撤回1 期
Phase 1, Open Label, Single Arm Study to Evaluate the Safety, Tolerability and Efficacy of MPT0B640 in Patients With COVID-19 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- J Ints Bio
- 主要终点
- MTD
研究概览
简要总结
Indication : Treatment of Subject with COVID-19 infection Phase : Phase I Duration of Study : 12 day Sample size : at least 15 subjects Methodology : Classical 3+3 design Investigational Product : MPT0B640, 15, 30, 60, 80 and 100mg, oral suspension Study Objective
- Primary Objective To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640
- Secondary Objectives To evaluate the safety and tolerability of MPT0B640 during entire study period To assess the efficacy of MPT0B640 To characterize the 48 hours PK of MPT0B640
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all inclusion criteria as listed below:
- •Age ≥18 years at time of signing Informed Consent Form
- •Laboratory (quantitative Polymerase Chain Reaction, qPCR) confirmed infection with 2019-nCoV.
- •Lung involvement confirmed with chest imaging
- •Hospitalized with a SaO2/SPO2≤94% on room air or PaO2/FiO2 ratio <300mgHg
- •≤7 days since illness onset
- •Must agree not to enroll in another study of an investigational agent prior to completion of Day 12 of study.
排除标准
- •Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
- •Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)
- •Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
- •Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
- •Will be transferred to another hospital which is not the study site within 72 hours.
- •Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
研究组 & 干预措施
MPT0B640
Other
There is single Arm in this clinical trials.
干预措施: MPT0B640 (Drug)
结局指标
主要结局
MTD
时间窗: 28days(+/-2days)
MTD is defined as highest dose level in which 6 subjects have been treated with less than 2 instances of DLT. DLT assessed during the study treatment period (28 ± 2 days) refers to a medically significant event which meets one of the criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
次要结局
- Viral load(Time Frame: Day 1, 3, 5, 7, 9 and 12)
- Time to clinical improvement(Time Frame: dialy up to Day 10)
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