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

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

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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