A Bioequivalence Study to Compare Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

Study Overview
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Brief Summary
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This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314. Subjects will be randomly assigned to the Vials group, the PFS group at a ratio of 1:1

Official Title
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A Single-center, Randomized, Parallel, Open-label , Bioequivalence Study to Compare the Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: SHR-1314


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained before any assessment is performed.Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations Men or women at least 18 years and no more than 45 years of age at time of screening. Men with a body weight ≥50 kg or women with a body weight ≥45kg, with BMI range from 18 to 25. Subjects with normal physical examination results and with normal laboratory results (blood, chemistry, urine, drug screening, coagulation function test), ECG and X-ray chest test are normal or with certain abnormal without clinical significance. Exclusion Criteria: Presence of significant medical problems, with investigator's judge that not proper to participate clinical study History of hypersensitivity to any of study drug constituent History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection. Those who have participated in any clinical study for any drug or medical device within 3 months before screening Those who have been vaccinated with live attenuated vaccine within 12 weeks prior to screening History or evidence of ongoing alcohol or drug abuse, within the last six months before Baseline. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. Subjects judged by the investigator as unsuitable for participating in this study.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>SHR-1314 Vial | Drug: SHR-1314<br>* each group subjects will be given different formulations of SHR-1314<br>|
| Active Comparator: Group B<br>SHR-1314 PFS | Drug: SHR-1314<br>* each group subjects will be given different formulations of SHR-1314<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-last: Area under the serum concentration-time curve from time zero to the last measurable concentration | Compare the AUC0-last of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 | 
| Cmax: Observed maximum serum concentration | Compare the Cmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 | 
| AUC0-∞: Area under the serum concentration-time curve from time zero to infinity | Compare the AUC0-∞ of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax : Time at which observed maximum concentration occurs | Compare the Tmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 | 
| CL/F: Apparent clearance | Compare the CL/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 | 
| t1/2: Terminal half-life | Compare the t1/2 of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 | 
| V/F:Apparent volume of distribution | Compare the V/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 | 
| Incidence and severity of adverse events (AEs). | Compare Incidence and severity of AE at 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 | 
| Anti-drug Antibodies (ADAs) | Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study. | from Day1 to Day113 |