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/AClinical Study ID
NCT05116410
HS-20094-101
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Screening weight of male ≥50 kg, female≥45 kg and 19≤BMI≤28
- 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
- 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:
- Pregnant or lactating women
- 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.
- Subjects with abnormal screening vital signs, physical examination, laboratoryexamination or 12 lead electrocardiogram results with clinical significance
- 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
- Received systemic steroid therapy, immunomodulator therapy or chemotherapy in the 3months prior to screening, or are likely to receive these treatments during the studyperiod
- 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
- 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
ChinaActive - Recruiting

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