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

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

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.

Study Overview

• Status: Completed
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: HMS5552

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201203
      • Hua Medicine Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HMS5552 dose 1; A single dose of HMS5552 tablets (5~50mg) taken orally.	Drug: Placebo; Drug: HMS5552
Experimental: HMS5552 dose 2; A single dose of HMS5552 tablets (5~50mg) taken orally.	Drug: Placebo; Drug: HMS5552
Experimental: HMS5552 dose 3; A single dose of HMS5552 tablets (5~50mg) taken orally.	Drug: Placebo; Drug: HMS5552
Experimental: HMS5552 dose 4; A single dose of HMS5552 tablets (5~50mg) taken orally.	Drug: Placebo; Drug: HMS5552
Experimental: HMS5552 dose 5; A single dose of HMS5552 tablets (5~50mg) taken orally.	Drug: Placebo; Drug: HMS5552
Experimental: HMS5552 dose 6; A single dose of HMS5552 tablets (5~50mg) taken orally.	Drug: Placebo; Drug: HMS5552

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Hua Medicine Limited
• Investigators: Principal Investigator: XueNing LI, MD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 22, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 30, 2013

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HMM0101