A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

Study Overview
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Brief Summary
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To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects

Official Title
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Pharmacokinetics, Safety and Immunogenicity of 14028 Injection Versus Dulaglutide Injection in Healthy Subjects: a Phase I ，Single-center, Randomized, Open-label, Single-dose, Parallel-controlled Clinical Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Biological: 14028 injection
* Biological: dulaglutide injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent form before the trial, understand and comply with the research process, and participate the trial voluntarily Healthy male subjects aged 18 to 45 (including the critical value) Weight > or = 50 kg, and 19.0 kg/m2 < or = BMI (body mass index) < or = 28.0 kg/m2 Vital signs, physical examination, laboratory examination, electrocardiogram, thyroid color Doppler ultrasound, abdominal color Doppler ultrasound and chest X-ray (anteroposterior) and other test results during screening are normal or have no clinical significance as judged by the investigator Subjects agree to use effective contraceptive methods from signing the informed consent form to the end of the trial drug use within 3 months, and there is no sperm donation plan. Exclusion Criteria: The investigator judges that the subjects have the following clinically significant diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) Have a medical or family history of medullary thyroid cancer (grandparents, parents, brothers and sisters), or a genetic disease that lead to medullary thyroid cancer; or a history or family history of multiple endocrine neoplasia syndrome type 2 Past or current history of pancreatitis (chronic or acute pancreatitis) Past or current history of habitual constipation or intestinal obstruction Clinically significant history of drug allergy or specific allergic disease (asthma, urticaria) or known allergy to the investigational drug and any component or related excipient components Those who have difficulty with venous blood collection, a history of needle sickness, haemorrhage, or a known tendency to severe bleeding Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIV), and Treponema pallidum antibody (TPAb) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products (except vitamin supplements) within 2 weeks before the first dose Those who have a history of vaccination with live attenuated vaccine within 3 months before screening or a history of vaccination with inactivated vaccine within 1 month before screening Those who have previously received dulaglutide or any other glucagon-like peptide-1 (GLP-1) analog Those who donated blood or lost blood > or = 400 mL within 3 months before screening, or those who plan to donate blood Those who smoked more than 5 cigarettes per day within 3 months before screening or who could not give up smoking during the period from signing the informed consent to the subjects leaving the group Those who have a history of alcohol abuse, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) , or those who have a positive alcohol breath test during the screening period Those who have a history of drug abuse or poison use within 2 years before screening, or those who have a positive test results for urine drug abuse screening during the screening period Participated in other clinical trials within 3 months before screening (subjects who are not randomized or not receiving treatment withdraw from the study before treatment, they can be enrolled in this study) Acute illness or concomitant medication occurred from the time of signing the informed consent to the first administration Those who have special requirements for diet and cannot obey the unified diet Others judged by the investigator to be unsuitable to participate in this trial Subjects who may not be able to complete this trial for other reasons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 14028 injection<br>Subjects receive 14028 injection in the study, 0.75mg, once | Biological: 14028 injection<br>* 14028 injection, single dose, s.c. injection<br>|
| Active Comparator: dulaglutide injection (TRULICITY®)<br>Subjects receive dulaglutide injection (TRULICITY®) in the study, 0.75mg, once | Biological: dulaglutide injection<br>* dulaglutide injection(TRULICITY®), single dose, s.c. injection<br>* Other names: TRULICITY®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum (peak) plasma drug concentration(Cmax) | Maximum (peak) plasma drug concentration | 0 hour (pre-dose,within 30mins) to 384 hours after administration | 
| Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞) | The area under the plasma concentration curve from 0 to ∞ | 0 hour (pre-dose, within 30mins) to infinity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | The area under the plasma concentration curve from 0 to 384 h | 0 hour (pre-dose,within 30mins) to 384 hours after administration | 
| Time to reach maximum plasma concentration following drug administration (Tmax) | Time to maximum concentration | 0 hour (pre-dose,within 30mins) to 384 hours after administration | 
| Elimination half-life (t1/2) | Elimination half-life | 0 hour (pre-dose,within 30mins) to 384 hours after administration | 
| Apparent total body clearance (CL/F) | Apparent total body clearance | 0 hour (pre-dose,within 30mins) to 384 hours after administration | 
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution | 0 hour (pre-dose,within 30mins) to 384 hours after administration | 
| Elimination constants (λz) | Elimination constants | 0 hour (pre-dose,within 30mins) to 384 hours after administration |