NCT01952535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

September 22, 2013

Last Update Submit

November 17, 2017

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (6)

HMS5552 dose 1

EXPERIMENTAL

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

Drug: HMS5552Drug: Placebo

HMS5552 dose 2

EXPERIMENTAL

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

Drug: HMS5552Drug: Placebo

HMS5552 dose 3

EXPERIMENTAL

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

Drug: HMS5552Drug: Placebo

HMS5552 dose 4

EXPERIMENTAL

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

Drug: HMS5552Drug: Placebo

HMS5552 dose 5

EXPERIMENTAL

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

Drug: HMS5552Drug: Placebo

HMS5552 dose 6

EXPERIMENTAL

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

Drug: HMS5552Drug: Placebo

Interventions

HMS5552DRUG
HMS5552 dose 1HMS5552 dose 2HMS5552 dose 3HMS5552 dose 4HMS5552 dose 5HMS5552 dose 6
PlaceboDRUG
HMS5552 dose 1HMS5552 dose 2HMS5552 dose 3HMS5552 dose 4HMS5552 dose 5HMS5552 dose 6

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hua Medicine Limited

Shanghai, Shanghai Municipality, 201203, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dorzagliatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • XueNing LI, MD

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2013

First Posted

September 30, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

CN(1)