Type 2 Diabetes
Conditions
Brief 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.
Interventions
DRUGHS-20094
Administrated SC
DRUGPlacebo
Administrated SC
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 egg donation for the duration of the study and for 6 months following the last dose of investigational product 3. Agree to avoid alcohol, foods and beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) from 48 hours prior to administration to last visit, and to avoid strenuous exercise
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 study by the investigator. 3. Subjects with abnormal screening vital signs, physical examination, laboratory examination 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) receptor agonism 5. Received systemic steroid therapy, immunomodulator therapy or chemotherapy in the 3 months prior to screening, or are likely to receive these treatments during the study period 6. Have a history of digestive disease (e.g., gastroesophageal reflux disease, gallbladder disease, or chronic enteritis) that may affect gastrointestinal adverse events 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 days of administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug | Time of Inform Consent Form to Day 29 (SAD) or Day 50 (MAD) | A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094 | Baseline to Day 22 (SAD) or Day 43 (MAD) | PK: AUC of HS-20094 |
| Pharmacokinetics (PK): Tmax of HS-20094 | Baseline to Day 22 (SAD) or Day 43 (MAD) | PK: Tmax of HS-20094 |
| Pharmacokinetics (PK): Cmax of HS-20094 | Baseline to Day 22 (SAD) or Day 43 (MAD) | PK: Cmax of HS-20094 |
| Pharmacodynamics (PD): AUC of insulin | Day 22 (MAD) | PD: AUC of insulin |
| Weight change | baseline to Day 29 (SAD) or Day 50 (MAD) | — |
| Pharmacodynamics (PD): AUC of glucose | Day 22 (MAD) | PD: AUC of glucose |
Countries
China
Contacts
Primary ContactYimin Cui, PhD
Outcome results
None listed