Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Volunteers

NCT02746302 | Completed Phase 1

• 1 other identifier: HS-20004-Ia
• Study Type: interventional
• Target: 62
• 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 of HS-20004 in healthy Chinese subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  From baseline up to 72 hours after single dose

Secondary Outcomes (4)

• Area under the plasma HS-20004 concentration versus time curve

  From time 0 to 72 hours after single dose

• Peak Plasma Concentration (Cmax) after dose

  From time 0 to 72 hours after single dose

• Terminal elimination half-life (t½) for HS-20004

  From time 0 to 72 hours after single dose

• 24-hour profiles of plasma glucose and serum insulin

  From time 0 to 24 hours after single dose

Study Arms (2)

HS-20004

EXPERIMENTAL

One dose of HS-20004(0.02,0.04,0.05,0.06,0.08,0.1mg) Injected s.c. (under the skin) once for one subject.

Drug: HS-20004

Placebo

PLACEBO COMPARATOR

Placebo Injected s.c. (under the skin) once for one subject.

Drug: Placebo

Interventions

HS-20004 DRUG

HS-20004

Placebo DRUG

Placebo

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 24 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, or serious unconscious hypoglycemia Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
• 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 of randomization
• Participated any drug clinical trials within 3 months, or participated 3 or more than 3 drug clinical trials in the near year, or had blood donation/loss \>400mL within 3 months

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: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 21, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share