Type II Diabetes Mellitus
Conditions
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.
Interventions
DRUGHMS5552
DRUGPlacebo
Sponsors
Hua Medicine Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements. | up to 72 hours post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour 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 | — |
Countries
China
Outcome results
None listed