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

Hansoh Pharma logo

Hansoh Pharma

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: HS-20004

Study type

Interventional

Funder types

Industry

Identifiers

NCT02746302
HS-20004-Ia

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body Mass Index (BMI) between 19 and 24 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, 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
  • 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

62 participants in 2 patient groups, including a placebo group

HS-20004
Experimental group
Description:
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.
Treatment:
Drug: HS-20004
Placebo
Placebo Comparator group
Description:
Placebo Injected s.c. (under the skin) once for one subject.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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