A Study of HS-20094 in Healthy Participants

Last updated: July 18, 2022
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

N/A

Clinical Study ID

NCT05116410
HS-20094-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study includes two parts (Single Ascending Dose, SAD; Multiple-Ascending Dose, MAD) and enrolls healthy participants. Participants in SAD accept single subcutaneous (SC) injection of HS-20094 and participants in MAD accept SC injection of HS-20094 once weekly for 4 weeks. The main purpose of this study is to determine 1) The safety of HS-20094; 2) How much HS-20094 gets into the bloodstream and how long it takes the body to get rid of it.3) How HS-20094 affects the levels of blood sugar, insulin and weight.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Screening weight of male ≥50 kg, female≥45 kg and 19≤BMI≤28
  2. Subjects agree to use an effective method of contraception and avoid sperm or eggdonation for the duration of the study and for 6 months following the last dose ofinvestigational product
  3. Agree to avoid alcohol, foods and beverages containing xanthine or caffeine (includingchocolate, tea, coffee, cola, etc.) from 48 hours prior to administration to lastvisit, and to avoid strenuous exercise

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Subjects have a medical history of cardiovascular, respiratory, liver, kidney,digestive tract, mental, neurological, hematology or metabolic abnormalities (e.g.,repeated hypoglycemia for unknown reasons) and are judged not suitable for this studyby the investigator.
  3. Subjects with abnormal screening vital signs, physical examination, laboratoryexamination or 12 lead electrocardiogram results with clinical significance
  4. Have a history of drug allergy, or known allergies to HS-20094, glucagon-like peptide (GLP)-1 analogs, or glucose-dependent insulinotropic polypeptide (GIP) receptoragonism
  5. Received systemic steroid therapy, immunomodulator therapy or chemotherapy in the 3months prior to screening, or are likely to receive these treatments during the studyperiod
  6. Have a history of digestive disease (e.g., gastroesophageal reflux disease,gallbladder disease, or chronic enteritis) that may affect gastrointestinal adverseevents assessment or any other gastrointestinal disease (e.g., gastric bypass surgery,pyloric stenosis, etc.) that may affect gastric emptying
  7. Have a diet, weight loss treatment or significant lifestyle changes prior to 30 daysof administration

Study Design

Total Participants: 68
Study Start date:
November 01, 2021
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Beijing University First Hospital

    Beijing, Beijing 110000
    China

    Active - Recruiting

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