The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject

Study Overview
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Brief Summary
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The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.

Official Title
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A Single Center, Randomized, Double-Blind, 2-period, 2-sequence Crossover Designed Study to Evaluate the Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject

Conditions
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Diabetes

Intervention / Treatment
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* Drug: HR011408 injection; NovoRapid®
* Drug: NovoRapid®；HR011408 injection
* Drug: HR011408 injection; NovoRapid®
* Drug: NovoRapid®；HR011408 injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained prior to any trial-related activities； Male or female subjects aged 18-55 years (both inclusive) at the time of signing informed consent； Body weight ≥50.0 kg for men and ≥45.0 kg for women, with body mass index (BMI) between 18.0 and 26.0 kg/m2 (both ends included)； Are nonsmokers, have not smoked for at least 6 months before entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or not use smokeless tobacco or nicotine products for the duration of the study. Exclusion Criteria: Have an abnormality in the 12-lead electrocardiogram (ECG) and as deemed to be clinically significant by the investigator; have a significant history of the circulatory system, respiratory system, digestive system, urinary system, hematopoietic system, endocrine and metabolic system, neuropsychiatric system, musculoskeletal system, or existing diseases in the above systems may affect the safety of the subjects and interfere with the study data. In the opinion of the investigator, are unsuitable for inclusion in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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
Interventional Model Description: Crossover Assigned to HR011408 or NovoRapid®
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>HR011408 injection + NovoRapid® | Drug: HR011408 injection; NovoRapid®<br>* HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.<br>|
| Experimental: Cohort 2<br>NovoRapid® + HR011408 injection | Drug: NovoRapid®；HR011408 injection<br>* NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.<br>|
| Experimental: Cohort 3<br>HR011408 injection + NovoRapid® | Drug: HR011408 injection; NovoRapid®<br>* HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.<br>|
| Experimental: Cohort 4<br>NovoRapid® + HR011408 injection | Drug: NovoRapid®；HR011408 injection<br>* NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.<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 (AUC0-0.5h) | Area under the concentration-time curve (AUC) | from 0 to 30 minutes after dose administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve (AUC0-15min) |  | from 0 to 15 minutes after dose administration | 
| Area under the concentration-time curve (AUC0-1h) |  | from 0 to 1 hour after dose administration | 
| Area under the concentration-time curve (AUC0-1.5h) |  | from 0 to 1.5 hours after dose administration | 
| Area under the concentration-time curve (AUC0-2h) |  | from 0 to 2 hours after dose administration | 
| Area under the concentration-time curve (AUC0-10h) |  | from 0 to 10 hours after dose administration | 
| Area under the concentration-time curve (AUC0-inf) |  | from 0 to infinity after dose administration | 
| Onset of appearance | First time point after dose administration when concentration reaches lower limit of quantification (LLOQ) | from 0 to 8 hours after dose administration | 
| Time to 50% maximum observed concentration (time to 50% Cmax) |  | from 0 to 8 hours after dose administration | 
| Time to maximum observed concentration (Tmax) |  | from 0 to 8 hours after dose administration | 
| Maximum observed concentration (Cmax) |  | from 0 to 8 hours after dose administration | 
| Elimination half-life (t1/2) |  | from 0 to 8 hours after dose administration | 
| Area under the GIR-time curve (AUC) | Area under the GIR-time curve (AUC0-10h) | from 0 to 10 hours after dose administration | 
| Time to 50% maximum observed GIR(time to 50% GIRmax) |  | from 0 to 10 hours after dose administration | 
| Time to maximum observed GIR (GIRmax) |  | from 0 to 10 hours after dose administration | 
| Incidence and severity of adverse events (AEs) |  | from Day1 to Day14 after dose administration |