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

NCT02746315 | Completed Phase 1

• 1 other identifier: HS-20004-Ib
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

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

Secondary Outcomes (4)

• 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

Study Arms (4)

Experimental 1

EXPERIMENTAL

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

Drug: HS-20004; Drug: Placebo

Experimental 2

EXPERIMENTAL

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

Drug: HS-20004; Drug: Placebo

Experimental 3

EXPERIMENTAL

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

Drug: HS-20004; Drug: Placebo

Experimental 4

EXPERIMENTAL

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

Drug: HS-20004; Drug: Placebo

Interventions

HS-20004 DRUG

Experimental 1; Experimental 2; Experimental 3; Experimental 4

Placebo DRUG

Experimental 1; Experimental 2; Experimental 3; Experimental 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 21, 2016
• Study Start: October 1, 2014
• Primary Completion: February 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share