A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Describe Pharmacokinetics/Pharmacodynamics, and the Safety and of SPH3127 Tablet in Chinese Healthy Volunteers

SPH3127-101

1. To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy volunteers. 2. To explore the appropriate dose and provide the basis for the subsequent clinical trials.

2016-12-01

2018-06-30

2018-07-30

Completed

Early phase I

48

Inclusion Criteria: * Healthy adults,age \>=18 years.Single gender should no less than a third of total subjects in each group. * BMI should be18 to 24 kg/m2 (including threshold), allowing the lowest weight 50 kg (including threshold) for the male and 45 kg (including threshold) for the female. * understand details of significance, benefit, inconvenience and potential danger of the research program, voluntarily signed informed consent. Exclusion Criteria: * during pregnancy, nursing mothers, and plans to test in the first 6 months (grant) pregnant; * abnormal results in physical examination, laboratory examination and have clinical significance (such as: liver function examination - aspartate aminotransferase (AST)/alanine aminotransferase (ALT) is more than 1.5 times of the upper limit of normal). * with cardiovascular, liver, kidney, gastrointestinal, nervous system, blood system and familial blood disease, thyroid dysfunction or abnormal mental illness; * has a history of drug allergy and allergic constitution; * took birth control pills within 6 weeks; * used any drugs (including Chinese herbal medicine) within 1 week; * participated in blood donation within 2 months ; * participated in any drug clinical trials (as subjects) within three months; * any positive result in virus serology check: human immunodeficiency virus antigen antibody (HIV Ag/Ab) 、hepatitis c virus (HCV) - IgG antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP); * addicted to cigarettes, alcohol, drink coffee, strong tea and drug abuse; * researchers think that exists any unfavorable factors to participate in the test.

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2022-10-27