A Trial Comparing the Pharmacodynamics and Pharmacokinetics of HR20014, INS068 and INS062 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS068）
研究概览
简要总结
This is a single-center, randomized, open, six-sequence, three-period crossover phase I clinical trial in healthy subjects to compare the PK/PD and safety profiles of single dose of HR20014, INS068, and INS062. In this study, 12 subjects were randomly assigned to 6 administration sequences in a ratio of 1:1:1:1:1:1, and HR20014, INS068 or INS062 injection were given subcutaneously three times before and after each sequence.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide a written informed consent;
- •Male or female aged 18-45 at screening (both inclusive);
- •Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator;
- •Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, body mass index (BMI) in 18.0~26.0 kg/m2 (both inclusive);
- •During the screening phase oral glucose tolerance test (OGTT), intravenous fasting plasma glucose ≥3.9 mmol/L and < 6.1 mmol/L; Glucose 2 hours after negative charge static pulse blood sugar <7.8mmol/L； and normal or abnormal insulin levels have no clinical significance.
排除标准
- •A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug;
- •Have a history of hypertension;
- •Severe systemic infectious diseases within 1 month before screening;
- •Patients with a history of lower extremity deep vein thrombosis or high risk of lower extremity deep vein thrombosis;
- •Patients with serious diseases of the psychiatric, cardiovascular, respiratory, digestive, endocrine, blood, urogenital and other systems in the past, or existing diseases of the above systems, were judged by the researchers to be unfit to participate in this study;
- •Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening;
- •Presence of any abnormal and clinically significant laboratory tests.
- •ECG (12-lead electrocardiogram) showed abnormal and clinically significant.
- •Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (the elder shall prevail), who participated in clinical trials are defined as random, prior to screening.
- •Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood ≥400 mL in the 3 months prior to screening.
- •Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
Treatment group sequence 1
Subjects were given HR20014, INS068, or INS062 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
干预措施: INS062 injection、INS068 injection、HR20014 injection (Drug)
Treatment group sequence 2
Subjects were given HR20014, INS062, or INS068 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
干预措施: INS062 injection、INS068 injection、HR20014 injection (Drug)
Treatment group sequence 3
Subjects were given INS068, HR20014, or INS062 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
干预措施: INS062 injection、INS068 injection、HR20014 injection (Drug)
Treatment group sequence 4
Subjects were given INS068, INS062, or HR20014 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
干预措施: INS062 injection、INS068 injection、HR20014 injection (Drug)
Treatment group sequence 5
Subjects were given INS062, HR20014, or INS068 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
干预措施: INS062 injection、INS068 injection、HR20014 injection (Drug)
Treatment group sequence 6
Subjects were given INS062, INS068, or HR20014 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
干预措施: INS062 injection、INS068 injection、HR20014 injection (Drug)
结局指标
主要结局
Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS068）
时间窗: 0 hour to 6 hours after dosing
Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS062）
时间窗: 6 hours to 24 hours after dosing
次要结局
- Area under the Glucose Infusion Rate (GIR) - time curve(0 hour to 10 hours after dosing)
- Maximum concentration of INS068(0 hour to 96 hours after dosing)
- Maximum concentration of INS062(0 hour to 10 hours after dosing)
- Incidence and severity of adverse events (AEs)(from screening to 7-21 days after the last dosing)