Single Ascending Dose Study of Safety and Tolerability of SPH3127 Tablet in Chinese Healthy Volunteers

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Criteria

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.