The Pharmacokinetics Study of Single and Multiple Dose of SP2086 in Healthy Volunteers

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose study the investigators evaluated the safety, tolerability and Pharmacokinetics profiles of SP2086 in healthy volunteers.

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

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• BMI(a measure of a person's weight in relation to height)is between 19 and 26 kg/m2,and the weight is equal or less than 100kg.

• without the history of cardiovascular diseases,liver diseases,kidney diseases,gastrointestinal tract diseases,mental nerve diseases and drug allergy.

• Be willing to accept physical contraception.

• Sign the informed consents voluntarily and ensure to completed the study.

Exclusion Criteria:

• Known allergy to SP2086 or any of the excipients of the formulation of SP2086;

• ever occured myocardial infarction,acute coronary syndrome, transient ischemic attack.

• the B hepatitis surface antigen or hepatitis C antibody or syphilis antibody or HIV antibody was positive.

• had participated three or more clinical trial in one year or had participated one time clinical medicine in one month of screening.

• have the history of blood donation in 3 months of screening or received the blood transfusion in 1 months of screening.

• have the history of tobacco,alcohol or drug abuse.

• History of or current clinically significant medical illness as determined by the Investigator.