A Phase I Study of SHR -2001 in Healthy Subjects

Study Overview
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Brief Summary
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This study is a phase 1 single dose escalation study of SHR-2001 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability,pharmacokinetics and Pharmacodynamics of SHR-2001 in healthy subjects

Official Title
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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2001 After a Single Subcutaneous Injection in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: SHR-2001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obtain informed consent from participants before the start of any study related activities. Participants must have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol; Age 18   55 years old (including boundary value), male or female; Weight ≥ 45 kg, body mass index (BMI) ranging 19   28 kg/m2 (including boundary value); Participants who are overtly healthy as determined by medical history and physical examination.; Participants and their partners have no fertility plan and voluntarily use highly effective contraception. Female subjects must have a negative serum pregnancy test and be non-lactating. Exclusion Criteria: Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks; Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial; Inactivated vaccine received within 2 weeks prior to randomization or live attenuated vaccine within 3 months prior to randomization, or intended to be vaccinated during the study period;

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects | Drug: SHR-2001<br>* Subcutaneous injection, single dose<br>Drug: Placebo<br>* Subcutaneous injection, single dose<br>|
| Experimental: Cohort 2<br>A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects | Drug: SHR-2001<br>* Subcutaneous injection, single dose<br>Drug: Placebo<br>* Subcutaneous injection, single dose<br>|
| Experimental: Cohort 3<br>A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects | Drug: SHR-2001<br>* Subcutaneous injection, single dose<br>Drug: Placebo<br>* Subcutaneous injection, single dose<br>|
| Experimental: Cohort 4<br>A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects | Drug: SHR-2001<br>* Subcutaneous injection, single dose<br>Drug: Placebo<br>* Subcutaneous injection, single dose<br>|
| Experimental: Cohort 5<br>A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects | Drug: SHR-2001<br>* Subcutaneous injection, single dose<br>Drug: Placebo<br>* Subcutaneous injection, single dose<br>|
| Experimental: Cohort 6<br>A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects | Drug: SHR-2001<br>* Subcutaneous injection, single dose<br>Drug: Placebo<br>* Subcutaneous injection, single dose<br>|
| Experimental: Experimental: Cohort 7<br>A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects | Drug: SHR-2001<br>* Subcutaneous injection, single dose<br>Drug: Placebo<br>* Subcutaneous injection, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence and severity of adverse events | Start of Treatment to end of study (approximately 50 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics-AUC0-t: | Area under the concentration-time curve from 0 to the last measurable time point after SHR-2001 administration | Start of Treatment to end of study (approximately 50 days) | 
| Pharmacokinetics-AUC0-inf： | Area under the concentration-time curve from time 0 to infinity after SHR-2001 administration | Start of Treatment to end of study (approximately 50 days) | 
| Pharmacokinetics-Cmax： | Maximum observed concentration of SHR-2001 | Start of Treatment to end of study (approximately 50 days) | 
| Pharmacokinetics-Tmax： | Time to Cmax | Start of Treatment to end of study (approximately 50 days) | 
| Pharmacokinetics-t1/2： | Terminal elimination half-life of SHR-2001 | Start of Treatment to end of study (approximately 50 days) | 
| Pharmacokinetics-CL/F | Apparent clearance of SHR-2001 | Start of Treatment to end of study (approximately 50 days)) | 
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of SHR-2001 | Start of Treatment to end of study (approximately 50 days)) | 
| Anti-Drug antibody | The percentage of subjects with positive ADA | Start of Treatment to end of study (approximately 50 days) |