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
|