NCT04235439已完成1 期
A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Lispro Injection With Both EU - Approved and US - Licensed Humalog® in Healthy Male Subjects
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年4月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cins.max
研究概览
简要总结
Primary objective:
To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference Products) in healthy male subjects
Secondary objectives:
To compare the PK and PD parameters of the three insulin lispro preparations
To evaluate the single dose safety and local tolerability of the three insulin lispro preparations
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent obtained before any trial related activities. Trial related activities are any procedures that would not have been done during normal management of the subject
- •Healthy male subjects
- •Age between 18 and 64 years, both inclusive
- •Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive
- •Fasting plasma glucose concentration <= 5.5 mmol/L (100 mg/dL) at screening
- •Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator
排除标准
- •Known or suspected hypersensitivity to IMP(s) or related product
- •Previous participation in this trial. Participation is defined as randomized
- •Receipt of any medicinal product in clinical development within 30 days before randomization in this trial
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- •Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator
- •Any history or presence of clinically relevant comorbidity, as judged by the Investigator
- •Signs of acute illness as judged by the Investigator
- •Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the Investigator
- •Clinically significant abnormal screening laboratory tests, as judged by the Investigator
- •Elevation of serum ALT> 10% above the ULN, or elevation of serum AST or serum bilirubin >20% above the ULN. (Note: Elevation of bilirubin is considered acceptable in case of Gilbert's disease and should be evaluated in clinical context)
- •Elevation of serum creatinine > ULN, or elevation of serum urea > 10% above ULN
- •Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
- •Symptoms of arterial hypotension
- •Heart rate at rest outside the range of 50-90 beats per minute
- •Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator
- •Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
- •Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day (on average)
- •A positive result in the alcohol and/or urine drug screen at the screening visit
- •Smoking more than 5 cigarettes or the equivalent per day
- •Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period
- •Positive test for Hepatitis Bs antigen
- •Positive test for Hepatitis C antibodies. (Presence of Hepatitis C antibodies will not lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain reaction is negative)
- •Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
- •Any medication (prescription and non-prescription drugs) within 7 days before IMP administration and/or anticoagulant therapy
- •Blood donation or blood loss of more than 500mL within the last 3 months
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- •Explanatory note on Exclusion Criterion 24: With the exception of paracetamol or NSAIDs for occasional use to treat acute pain, as judged by the Investigator.
研究组 & 干预措施
Gan & Lee Insulin Lispro Injection
Experimental
Insulin lispro, 3 mL cartridge in prefilled pen, 100 units/mL (U-100)
干预措施: Gan & Lee Insulin Lispro Injection (Drug)
EU - approved Humalog ®
Active Comparator
Insulin lispro (product approved and marketed in the EU), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100)
干预措施: Gan & Lee Insulin Lispro Injection (Drug)
US - licensed Humalog ®
Active Comparator
Insulin lispro (product approved and marketed in the US), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100)
干预措施: Gan & Lee Insulin Lispro Injection (Drug)
结局指标
主要结局
Cins.max
时间窗: 0 to 12 hours
PK Endpoint: The maximum observed insulin concentration.
AUCins.0-12h
时间窗: 0 to 12 hours
PK Endpoint: The area under the insulin concentration curve from 0 to 12 hours.
AUCGIR.0-12h
时间窗: 0 to 12 hours
PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours.
GIRmax
时间窗: 0 to 12 hours
PD endpoint: The maximum glucose infusion rate.
次要结局
- AUCins.0-∞(0 to 12 hours)
- AUCins.0-4h(0 to 4 hours)
- AUCins.0-6h(0 to 6 hours)
- AUCins.6-12h(6 to 12 hours)
- tins.max(0 to 12 hours)
- t50%-ins(early)(0 to 12 hours)
- AUCins.0-2h(0 to 2 hours)
- t50%-ins(late)(0 to 12 hours)
- t½(0 to 12 hours)
- λz(0 to 12 hours)
- AUCGIR.0-2h(0 to 2 hours)
- AUCGIR.0-4h(0 to 4 hours)
- AUCGIR.0-6h(0 to 6 hours)
- AUCGIR.6-12h(6 to 12 hours)
- tGIR.max(0 to 12 hours)
- tGIR.50%-early(0 to 12 hours)
- tGIR.50%-late(0 to 12 hours)
- PD endpoint(0 to 12 hours)
- Safety and Local Tolerability(0 to 12 hours)
研究者
研究点 (1)
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