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

Information source: Hua Medicine Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type II Diabetes Mellitus

Intervention: HMS5552 (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hua Medicine Limited

Official(s) and/or principal investigator(s):
XueNing LI, MD, Principal Investigator, Affiliation: Shanghai Zhongshan Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2.

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

Hua Medicine Limited, Shanghai, Shanghai 201203, China
Additional Information

Starting date: September 2013
Last updated: February 18, 2014

Page last updated: August 23, 2015

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