A Phase 1a, Single-Dose, Open-Label, Parallel, Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled MKC253 in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
研究概览
简要总结
26 subjects will be enrolled into 5 different dose groups. The trial will consist of a screening, a dosing and a follow-up visit.
Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given at 5 dose levels.
详细描述
This Phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to determine the safety & tolerability of MKC253 (GLP1/Technosphere®)Inhalation Powder.
The trial consists of a screening, dosing and a follow-up visit. Single dose administration of MKC253 occurs at the dosing visit. Five doses are being assessed: 0.05, 0.45, 0.75, 1.05 & 1.5 mg GLP-1. Dosing of each ascending cohort will occur after the Principal Investigator has reviewed all safety/tolerability data
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males = 18 and = 45 years of age
- •Written Informed Consent.
- •Body Mass Index (BMI) of < 30 kg/m2
- •Non-smoker
- •Normal pulmonary function and performance on pulmonary function tests
排除标准
- •Clinically significant disease including diabetes mellitus
- •Fasting blood glucose > 110 mg/dL (6.1 mmol/L)
- •Significant psychiatric condition or drug or alcohol abuse
- •Any other condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial
- •Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria
研究组 & 干预措施
1
MKC253 Inhalation Powder
干预措施: MKC253 Inhalation Powder (Drug)
结局指标
主要结局
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
时间窗: 2 weeks
次要结局
- Incidence of pulmonary and other AEs(2 weeks)
- Pharmacokinetic (PK) parameters of plasma GLP-1(2 weeks)