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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: HS-20004

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 1; Once daily subcutaneous dose for 7 Days of HS-20004 0.02 mg or Matched Placebo.	Drug: Placebo; Drug: HS-20004
Experimental: Experimental 2; Once daily subcutaneous dose for 7 Days of HS-20004 0.04 mg or Matched Placebo.	Drug: Placebo; Drug: HS-20004
Experimental: Experimental 3; Once daily subcutaneous dose for 7 Days of HS-20004 0.06 mg or Matched Placebo.	Drug: Placebo; Drug: HS-20004
Experimental: Experimental 4; Once daily subcutaneous dose for 7 Days of HS-20004 0.08 mg or Matched Placebo.	Drug: Placebo; Drug: HS-20004

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of treatment emergent adverse events (TEAEs)	Day 0 and up to 3 days after last treatment (Day 10)

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HS-20004-Ib

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO