Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple s.c Doses HS-20004 in Healthy Chinese Volunteers

NCT ID: NCT02746315

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31

Brief Summary

This trial is conducted in China. The aim of this trial is to assess the safety and tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental 1

Once daily subcutaneous dose for 7 Days of HS-20004 0.02 mg or Matched Placebo.

Group Type: EXPERIMENTAL

HS-20004

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Experimental 2

Once daily subcutaneous dose for 7 Days of HS-20004 0.04 mg or Matched Placebo.

Group Type: EXPERIMENTAL

HS-20004

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Experimental 3

Once daily subcutaneous dose for 7 Days of HS-20004 0.06 mg or Matched Placebo.

Group Type: EXPERIMENTAL

HS-20004

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Experimental 4

Once daily subcutaneous dose for 7 Days of HS-20004 0.08 mg or Matched Placebo.

Group Type: EXPERIMENTAL

HS-20004

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

HS-20004

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body Mass Index (BMI) between 19 and 28 kg/m^2, inclusive, and a total body weight of at least 50 kg;

Exclusion Criteria

• Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator;
• Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol;
• Family history of diabetes, thyroid cancer, submandibular gland cancer, or history of pancreatitis, cholelithiasis, drug allergy, serious unconscious hypoglycemia or positive of anxious chronic viral hepatitis B, HIV antibody;
• History of drug or alcohol abuse within 6 months before randomization;
• Use of GLP-1 analogues, DPP-IV enzyme inhibitors, as well as other hypoglycemic drugs within 3 months before randomization;
• Use of any prescription drugs and Chinese herbal medicines within 4 weeks before randomization;
• Use of non prescription drugs and food supplements (vitamins, etc.) within 2 weeks before randomization;
• Participated any drug clinical trials within 3 months, or participated 3 or more than 3 drug clinical trials within 1 year, or had blood donation/loss >400mL within 3 months before randomization;
• Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization;
• Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration; Subject who is unsuitable for inclusion in the 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

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HS-20004-Ib

Identifier Type: -

Identifier Source: org_study_id