A Trial of SHR8735 in Healthy Subjects

Study Overview
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Brief Summary
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This is a phase 1 open-label study.

Detailed Description
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This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR8735 in healthy subjects

Official Title
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A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of SHR8735 in Healthy Chinese and Caucasian Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: SHR8735


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent. Be able to comply with all the requirements and able to complete the study. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration. Exclusion Criteria: Receipt of any other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form). History of illicit or prescription drug abuse or addiction within one year of screening, or positive urine drug screen at screening and Day-1. The urine drug screen may be repeated at the discretion of the investigator and the reason for repeat needs to be documented clearly (e.g., suspicion of false positive due to diet). Severe, active psychiatric conditions that require ongoing treatment.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: SHR8735 cohort 1<br>The subjects will receive a multiple dose of SHR8735 (low dose). | Drug: SHR8735<br>* SHR8735 is an thrombopoietin receptor agonist to promote platelet production.<br>|
| Experimental: Experimental: SHR8735 cohort 2<br>The subjects will receive a single dose of SHR8735 (medium dose). | Drug: SHR8735<br>* SHR8735 is an thrombopoietin receptor agonist to promote platelet production.<br>|
| Experimental: Experimental: SHR8735 cohort 3<br>The subjects will receive a single dose of SHR8735 (high dose). | Drug: SHR8735<br>* SHR8735 is an thrombopoietin receptor agonist to promote platelet production.<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 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics-AUC0-last | Area under the concentration-time curve from time 0 to last time point after SHR8735 administration | Start of Treatment to end of study (approximately 15 days) | 
| Pharmacokinetics-AUC0-inf | Area under the concentration-time curve from time 0 to infinity after SHR8735 administration | Start of Treatment to end of study (approximately 15 days) | 
| Pharmacokinetics-Tmax | Time to Cmax of SHR8735 | Up to 15 days | 
| Pharmacokinetics-Cmax | Maximum observed concentration of SHR8735 | Up to 15 days | 
| Pharmacokinetics-CL/F | Apparent clearance of SHR8735 | Up to 15 days | 
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of SHR8735 | Up to 15 days | 
| Pharmacokinetics-t1/2 | Terminal elimination half-life of SHR8735 | Up to 15 days | 
| Change from baseline to end of treatment for platelet count |  | Up to 28 days |