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

NCT ID: NCT01952535

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Type II Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HMS5552 dose 1

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

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

Placebo

Intervention Type DRUG

HMS5552 dose 2

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

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

Placebo

Intervention Type DRUG

HMS5552 dose 3

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

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

Placebo

Intervention Type DRUG

HMS5552 dose 4

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

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

Placebo

Intervention Type DRUG

HMS5552 dose 5

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

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

Placebo

Intervention Type DRUG

HMS5552 dose 6

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

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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HMS5552

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hua Medicine Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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XueNing LI, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

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Hua Medicine Limited

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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HMM0101

Identifier Type: -

Identifier Source: org_study_id