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

Simcere

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: Simotinib Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

SIM-101

Details and patient eligibility

About

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

Enrollment

63 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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