A Randomized, Double-blind, Placebo-controlled Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Study of Administrating Single Ascending Dose of HMS5552 in Healthy Adult Volunteers

Hua Medicine Limited1 site in 1 country60 target enrollmentSeptember 2013

ConditionsType II Diabetes Mellitus

InterventionsHMS5552 Placebo

DrugsHMS5552 Placebo

Overview

Phase: Phase 1
Intervention: HMS5552
Conditions: Type II Diabetes Mellitus
Sponsor: Hua Medicine Limited
Enrollment: 60
Locations: 1
Primary Endpoint: Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

This will be a randomized, double-blind and placebo-controlled safety study with single oral doses of HMS5552 given to healthy volunteers. The primary objective is to characterize the safety profiles of HMS5552 following single ascending doses (SAD) in healthy adult subjects. The secondary objectives include: 1. To assess the pharmacokinetic profiles of HMS5552 after single dosing 2. To assess the preliminary pharmacodynamic profiles of HMS5552 Each study subject will receive a single oral dose of HMS5552. During each dosing, eight subjects will be allocated to receive HMS5552 and two subjects will be allocated to receive placebo treatment. Several doses of HMS5552 will be tested. Dose titration or reduction is determined for each cohort based on the safety and pharmacokinetic data obtained from the lower dose cohorts.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

December 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hua Medicine Limited

Responsible Party

Sponsor

Eligibility 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

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.

Time Frame: up to 72 hours post-dose

Secondary Outcomes

The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2.(up to 72 hours post-dose)
Pharmacodynamic variables will include maximum change (%) in fasting plasma glucose level, AUC0-4 of fasting plasma glucose , AUC of percent reduction in fasting plasma glucose from baseline versus time curve, time of minimum glucose level(up to 6 hours post-dose)