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

Primary Purpose

Type II Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HMS5552

Placebo

About this trial

This is an interventional treatment trial for Type II Diabetes Mellitus

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hua Medicine Limited

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

HMS5552 dose 1

HMS5552 dose 2

HMS5552 dose 3

HMS5552 dose 4

HMS5552 dose 5

HMS5552 dose 6

Arm Description

A single dose of HMS5552 tablets (5~50mg) taken orally.

Outcomes

Primary Outcome Measures

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 Measures

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.

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

Full Information

NCT ID

NCT01952535

First Posted

September 22, 2013

Last Updated

November 17, 2017

Sponsor

Hua Medicine Limited

1. Study Identification

Unique Protocol Identification Number

NCT01952535

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hua Medicine Limited

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: To assess the pharmacokinetic profiles of HMS5552 after single dosing 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type II Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HMS5552 dose 1

Arm Type

Experimental

Arm Description

A single dose of HMS5552 tablets (5~50mg) taken orally.

Arm Title

HMS5552 dose 2

Arm Type

Experimental

Arm Description

A single dose of HMS5552 tablets (5~50mg) taken orally.

Arm Title

HMS5552 dose 3

Arm Type

Experimental

Arm Description

A single dose of HMS5552 tablets (5~50mg) taken orally.

Arm Title

HMS5552 dose 4

Arm Type

Experimental

Arm Description

A single dose of HMS5552 tablets (5~50mg) taken orally.

Arm Title

HMS5552 dose 5

Arm Type

Experimental

Arm Description

A single dose of HMS5552 tablets (5~50mg) taken orally.

Arm Title

HMS5552 dose 6

Arm Type

Experimental

Arm Description

A single dose of HMS5552 tablets (5~50mg) taken orally.

Intervention Type

Drug

Intervention Name(s)

HMS5552

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Description

Time Frame

up to 72 hours post-dose

Title

Time Frame

up to 6 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

XueNing LI, MD

Organizational Affiliation

Shanghai Zhongshan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hua Medicine Limited

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201203

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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