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

Type II Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952535
• Other study ID #: HMM0101
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2013
• Last updated: November 17, 2017
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2017
• Source: Hua Medicine Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

Drug:
• HMS5552

• Placebo

Locations

Country	Name	City	State
China	Hua Medicine Limited	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hua Medicine Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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