NCT06375031招募中1 期
Comparing Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Subjects With Diabetics- A Randomized, Double-Blind, Three-cycle Crossover Phase I Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area under the serum concentration-time curve of insulin aspart
研究概览
简要总结
The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects had to meet all the following criteria to enrol this study
- •Male or female aged 18-64 years (both inclusive)；
- •Body mass index 18.5-35.0 kg/m2 (both inclusive)；
- •Diagnosed with type 1 diabetes or type 2 diabetes≥ 12 months at screening；
- •HbA1c ≤9.0% by local laboratory at screening；
- •Current treatment with any basal-bolus insulin regimen or continuous subcutaneous insulin infusion(CSII) for ≥ 8 weeks. Patients with type 2 diabetes can also take metformin but require a stable metformin dose for ≥8 weeks；
- •Current total daily insulin treatment < 1.2 U/kg/day, and total daily bolus insulin treatment ≥ 0.3 U/kg/day and < 0.7 U/kg/day.
排除标准
- •Subjects who meet any of the following criteria will be excluded from this study.
- •The following laboratory or ancillary abnormalities were present from screening until randomization:
- •Poor blood pressure control, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
- •Subject has any history or evidence meet the following diseases or conditions:
- •have had severe hypoglycaemia episodes within 6 months before screening as judged by the investigator.
- •Have hospitalization due to diabetic ketoacidosis or hyperglycaemic hyperosmolar state within 6 months prior to screening;
- •Proliferative retinopathy, maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.
- •Previous and anticipated concomitant treatments:
- •Not able or willing to refrain from any use of herbal products and non-routine vitamins within 14 days or within 5 half-lives (whichever is longer), and routine vitamins within 48 hours prior to trial product administration
- •Within 1 month or have within 5 half-lives (whichever is longer) participated in any trail (defined participate in trail as having had randomized) of using investigational drug or therapy prior to screening.
- •General information:
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent nicotine per day).
- •Previous participation in this study. Participation was defined as randomised.
- •Any other situation judged by investigator that may endanger the safety of the subjects or influence the evaluation of the results.
研究组 & 干预措施
Arm 1: Medication regimen A-B-C
Experimental
干预措施: HR011408 injection Placebo; HR011408 injection (Drug)
Arm 2: Medication regimen B-C-A
Experimental
干预措施: NovoRapid®; HR011408 injection Placebo (Drug)
Arm 2: Medication regimen B-C-A
Experimental
干预措施: HR011408 injection; HR011408 injection Placebo (Drug)
Arm 1: Medication regimen A-B-C
Experimental
干预措施: NovoRapid®; HR011408 injection Placebo (Drug)
Arm 1: Medication regimen A-B-C
Experimental
干预措施: HR011408 injection; HR011408 injection Placebo (Drug)
Arm 2: Medication regimen B-C-A
Experimental
干预措施: HR011408 injection Placebo; HR011408 injection (Drug)
Arm 3: Medication regimen C-A-B
Experimental
干预措施: HR011408 injection; HR011408 injection Placebo (Drug)
Arm 3: Medication regimen C-A-B
Experimental
干预措施: NovoRapid®; HR011408 injection Placebo (Drug)
Arm 3: Medication regimen C-A-B
Experimental
干预措施: HR011408 injection Placebo; HR011408 injection (Drug)
结局指标
主要结局
Area under the serum concentration-time curve of insulin aspart
时间窗: From 0 to 30 mins after trial product administration
次要结局
- Plasma glucose concentration(From 0 to 6 hours after start of a standardised meal)
- Number of subjects with adverse events and severity of adverse events(From first dose to the last visit, approximately 2 months)
- Area under the serum concentration-time curve of insulin aspart(From 0 to 6 hours after trial product administration)
研究者
研究点 (1)
Loading locations...
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