Clinical Trials/NCT02746315

NCT02746315

Completed

Phase 1

A Randomised, Double-blind, Single-centre, Placebo-controlled, Dose Escalation, Multiple s.c. DoseStudy to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Subjects

Jiangsu Hansoh Pharmaceutical Co., Ltd.0 sites40 target enrollmentOctober 2014

ConditionsHealthy

InterventionsHS-20004 Placebo

DrugsHS-20004 Placebo

Overview

Phase: Phase 1
Intervention: HS-20004
Conditions: Healthy
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Enrollment: 40
Primary Endpoint: Number of treatment emergent adverse events (TEAEs)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

February 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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;

Arms & Interventions

Experimental 1

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

Intervention: HS-20004

Experimental 2

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

Intervention: Placebo

Experimental 1

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

Intervention: Placebo

Experimental 2

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

Intervention: HS-20004

Experimental 3

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

Intervention: HS-20004

Experimental 3

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

Intervention: Placebo

Experimental 4

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

Intervention: HS-20004

Experimental 4

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

Intervention: Placebo

Outcomes

Primary Outcomes

Number of treatment emergent adverse events (TEAEs)

Time Frame: Day 0 and up to 3 days after last treatment (Day 10)

Secondary Outcomes

Area under the plasma HS-20004 concentration curve after the last s.c injection(Time 0 to 72 hours after the last dose)
Peak plasma concentration (Cmax) after the last dose(Time 0 to 72 hours after the last treatment)
Terminal elimination half-life (t½) for HS-20004 after the last dose(Time 0 to 72 hours after the last treatment)
Change in 24-hour profiles of plasma glucose and serum insulin from baseline(From time 0 to 24 hours after the first and last treatment)