A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study is to determine the safety profiles, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy adult subjects.

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

Details

• Lead Sponsor: Hua Medicine Limited

Criteria

Inclusion Criteria:

• Female and male volunteers, 18 to 45 years of age

• BMI: 18 to 24 kg/m2

• Fasting plasma glucose: 3.9 to 6.1 mmol/L

• Glucose level at 2 hours following oral glucose tolerance test <7.8 mmol/L

• HbA1c: 4 to 6.5%

• Normal supine blood pressure and normal ECG recordings

Exclusion Criteria:

• Female with child-bearing potential

• Evidence of clinically-significant renal, cardiac, bronchopulmonary, vascular, gastrointestinal, allergic, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis or cirrhosis.

• Intake of grapefruit or anything that may affect liver enzyme function within 1 month prior to the dosing day

• Clinically-relevant deviation from normal in the physical examination

• Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator