Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and pharmacokinetics of single ascending doses of Simotinib Hydrochloride in healthy subjects.

Official Title
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Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Simotinib Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy , male or female subjects Age of 18 to 45 years Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight > 50 kg for male, > 45 kg for female Written informed consent signed and dated by the subject Subjects who are willing and able to comply with study procedures Exclusion Criteria: Any clinically significant disease or surgery within 4 weeks prior to the beginning of the study Known hypersensitivity to the study drug or similar drugs History of any serious disease, including but not limited to circulatory system, endocrine system, central nervous system, hematology, immunology, metabolic diseases and psychiatric disorders History of gastrointestinal, hepatic, and renal diseases, affecting drug absorption and metabolism Any clinically significant abnormal clinical laboratory tests Abnormal ECG or vital signs A positive test for HIV antibody A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result History of alcohol consumption within six months of the study defined as: an average weekly intake of > 14 units History of regular tobacco use or nicotine containing products within three months prior to screening Consumption of too much tea or coffee (> 8 cups/day) Use of any drug, which inhibits or induces hepatic drug metabolism, within 30 days prior to the beginning of the study Use of any drug within 14 days prior to the beginning of the study Participate in other clinical trials within 30 days prior to the beginning of the study Blood donation within 30 days of dosing All female subjects must not be of child-bearing potential Pregnant or lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simotinib<br> | Drug: Simotinib Hydrochloride<br>* Single ascending doses: 25 mg、50 mg、100 mg、150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single ascending doses: 150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of adverse events |  | within 7 days following administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum plasma concentration (Cmax) |  | 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h | 
| The time to Cmax (tmax) |  | 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h | 
| Area under the plasma concentration-time curve (AUC) |  | 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h | 
| The Terminal half-life (t1/2) |  | 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h |