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

Phase 1CompletedNCT01952535

Hua Medicine Limited60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type II Diabetes Mellitus

Interventions

HMS5552DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Hua Medicine Limited

Shanghai, Shanghai Municipality, China

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.

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.

Time frame: 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

Time frame: up to 6 hours post-dose

Data from ClinicalTrials.gov

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