A Study of HS-20094 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: HS-20094
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 egg donation for the duration of the study and for 6 months following the last dose of investigational product 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: 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 study by the investigator. Subjects with abnormal screening vital signs, physical examination, laboratory examination 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) receptor agonism 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 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 Have a diet, weight loss treatment or significant lifestyle changes prior to 30 days of administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HS-20094 (Single dose)<br>Escalating doses of HS-20094 administered subcutaneously (SC) once in healthy participants. | Drug: HS-20094<br>* Administrated SC<br>* Other names: HS-20094 injection;|
| Experimental: HS-20094 (Multiple doses)<br>Escalating doses of HS-20094 administered SC once weekly for four weeks in healthy participants. | Drug: HS-20094<br>* Administrated SC<br>* Other names: HS-20094 injection;|
| Placebo Comparator: Placebo (Single dose)<br>Placebo administered SC once in healthy participants. | Drug: Placebo<br>* Administrated SC<br>* Other names: Placebo injection;|
| Placebo Comparator: Placebo (Multiple doses)<br>Placebo administered SC once weekly for four weeks in healthy participants. | Drug: Placebo<br>* Administrated SC<br>* Other names: Placebo injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug | 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 | Time of Inform Consent Form to Day 29 (SAD) or Day 50 (MAD) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Cmax of HS-20094 | PK: Cmax of HS-20094 | Baseline to Day 22 (SAD) or Day 43 (MAD) | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094 | PK: AUC of HS-20094 | Baseline to Day 22 (SAD) or Day 43 (MAD) | 
| Pharmacokinetics (PK): Tmax of HS-20094 | PK: Tmax of HS-20094 | Baseline to Day 22 (SAD) or Day 43 (MAD) | 
| Pharmacodynamics (PD): AUC of glucose | PD: AUC of glucose | Day 22 (MAD) | 
| Pharmacodynamics (PD): AUC of insulin | PD: AUC of insulin | Day 22 (MAD) | 
| Weight change |  | baseline to Day 29 (SAD) or Day 50 (MAD) |