A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.

Official Title
-----------------
A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

Conditions
-----------------
Diabetes in Adults

Intervention / Treatment
-----------------
* Drug: HR011408 injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-55 years(both inclusive) at the time of signing informed consent Body mass index 18.0-26.0kg/m2(both inclusive) Body weight ≥50.0kg(male),≥45.0kg(female) Fasting serum/plasma glucose <6.1mmol/L Exclusion Criteria: Known or suspected of being allergic to any ingredient in the study drug. Participated in any drug or medical device-related clinical trial within 3 months before screening. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration Donated blood within 1 month before screening; or donated blood ≥400 mL or had blood loss ≥400 mL during trauma or major surgery within 3 months before screening. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort one: Low dose<br>Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively | Drug: HR011408 injection<br>* Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.<br>|
| Experimental: Cohort two: Medium dose<br>Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively | Drug: HR011408 injection<br>* Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.<br>|
| Experimental: Cohort three: high dose<br>Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively | Drug: HR011408 injection<br>* Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events (AEs) | The incidence of adverse events will be collected and the safety of HR011408 will be assessed | from Day1 to Day15 | 
| Area under the concentration-time curve (AUC) | Area under the concentration-time curve (AUC) | from 0 to 10 hours after dose administration | 
| Maximum observed concentration (Cmax) | Maximum observed concentration (Cmax) | from 0 to 10 hours after dose administration | 
| Time to maximum observed concentration (Tmax) | Time to maximum observed concentration (Tmax) | from 0 to 10 hours after dose administration | 
| Elimination half-life (t1/2) | Elimination half-life (t1/2) | from 0 to 10 hours after dose administration | 
| Time to 50% maximum observed concentration (time to 50% Cmax) | Time to 50% maximum observed concentration (time to 50% Cmax) | from 0 to 10 hours after dose administration | 
| Onset of appearance | First time point after dose administration when concentration reaches lower limit of quantification (LLOQ) | from 0 to 10 hours after dose administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of development of Anti-drug Antibodies (ADAs) | Incidence of Anti-drug Antibodies (ADAs) will be assessed | from Day1 to Day15 after dose administration |