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

• Sponsor: Hua Medicine Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01952535
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 6
• Duration (Months): 3
• Patients Per Site Per Month: 20.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes Mellitus	Drug: HMS5552; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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]

   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.

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hua Medicine Limited	Shanghai	Shanghai	China	201203

Sponsors and Collaborators

• Hua Medicine Limited

Investigators

• Principal Investigator: XueNing LI, MD, Shanghai Zhongshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hua Medicine Limited
• ClinicalTrials.gov Identifier: NCT01952535
• Other Study ID Numbers: HMM0101
• First Posted: Sep 30, 2013
• Last Update Posted: Nov 20, 2017
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 20, 2017