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

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Hansoh Pharma

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: HS-20004

Study type

Interventional

Funder types

Industry

Identifiers

NCT02746315
HS-20004-Ib

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 4 patient groups

Experimental 1
Experimental group
Description:
Once daily subcutaneous dose for 7 Days of HS-20004 0.02 mg or Matched Placebo.
Treatment:
Drug: HS-20004
Drug: Placebo
Experimental 2
Experimental group
Description:
Once daily subcutaneous dose for 7 Days of HS-20004 0.04 mg or Matched Placebo.
Treatment:
Drug: HS-20004
Drug: Placebo
Experimental 3
Experimental group
Description:
Once daily subcutaneous dose for 7 Days of HS-20004 0.06 mg or Matched Placebo.
Treatment:
Drug: HS-20004
Drug: Placebo
Experimental 4
Experimental group
Description:
Once daily subcutaneous dose for 7 Days of HS-20004 0.08 mg or Matched Placebo.
Treatment:
Drug: HS-20004
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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