Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects

Study Overview
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Brief Summary
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This study was divided into two parts. The aim of this study is to investigate the bioequivalence of INS062 injection andNovoRapid ® in healthy subjects(Part I), and to investigate the pharmacokinetics and pharmacodynamics of single dose of HR20014 injection and BIAsp 30 in healthy subjects(Part II).

Official Title
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Bioequivalence Studyof INS062 Injection and NovoRapid ®in Healthy Subjects and Pharmacokinetics and Pharmacodynamics Study of Single Subcutaneous Injection of HR20014 in Healthy Subjects

Conditions
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Diabetes

Intervention / Treatment
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* Drug: INS062 injection
* Drug: Insulin Aspart
* Drug: HR20014 injection
* Drug: Insulin Aspart 30 Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects aged 18   45 (including the boundary. value)(Part I). Subjects aged 18   45 (including the boundary value), male or female(Part II). 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 Body Mass Index (BMI) between 18.0-26.0 kg/m2 (both inclusive). Exclusion Criteria: 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. 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. 12-lead electrocardiogram (ECG) showed abnormal and clinically significant. Known or suspected history of drug abuse or positive urine drug screening test within screening period. 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; Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.

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

Sexes Eligible for Study
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All

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INS062<br> | Drug: INS062 injection<br>* Part I: A single dose of 1.2noml/kg is administered.<br>|
| Active Comparator: NovoRapid ®<br> | Drug: Insulin Aspart<br>* Part I: A single dose of 0.2U/kg is administered.<br>|
| Experimental: HR20014<br> | Drug: HR20014 injection<br>* Part II: Ascending single doses at three dose levels<br>|
| Active Comparator: BIAsp 30<br> | Drug: Insulin Aspart 30 Injection<br>* Part II: A single dosewas administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve （Part I） | Linear Up Log Down | 0 to 10 hours after dosing | 
| Maximum concentration（Part I） | Observed value | 0 to 10 hours after dosing | 
| Area under the Glucose Infusion Rate (GIR) - time curve （Part I） | Based on smoothed data | 0 to 10 hours after dosing | 
| Maximum GIR （Part I） | Based on smoothed data | 0 to 10 hours after dosing | 
| Area under the Glucose Infusion Rate (GIR) - time curve （Part II） | Based on smoothed data | 0h to 24 hours after dosing | 
| Maximum GIR（Part II） | Based on smoothed data | 0 to 24 hours after dosing | 
| Time to maximum GIR （Part II） | Based on smoothed data | 0 to 24 hours after dosing | 
| Area under the concentration-time curve （Part II） | Linear Up Log Down | 0 to 120 hours after dosing | 
| Maximum concentration（Part II） | Observed value | 0 to 120 hours after dosing | 
| Time to maximum concentration （Part II） | Observed value | 0 to 120 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximum concentration （Part I） | Observed value | 0 to 10 hours after dosing | 
| Terminal half-life （Part I） | Terminal half-life of insulin aspart | 0 to 10 hours after dosing | 
| Time to maximum GIR （Part I） | Based on smoothed data | 0 to 10 hours after dosing | 
| Incidence of anti-drug antibody (ADA)（Part I） | Incidence of ADA for insulin aspart | from 0 hour after dosing to 3-14 days after the last dose | 
| Incidence and severity of adverse events (AEs)（Part I） | The safety of test drug will be assessed | from screening to 3-14 days after the last dose | 
| Incidence of anti-drug antibody (ADA)（Part II） |  | from 0 hour to 7-21 days after the last dose | 
| Incidence and severity of adverse events (AEs)（Part II） | The safety of test drug will be assessed | from screening to 7-21 days after the last dose |