A Study of HS-20094 in Healthy Participants

Hansoh Pharma

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: HS-20094

Study type: Interventional

Funder types: Industry

Identifiers

NCT05116410

HS-20094-101

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 4 patient groups, including a placebo group

HS-20094 (Single dose)

Experimental group

Description:

Escalating doses of HS-20094 administered subcutaneously (SC) once in healthy participants.

Treatment:

Drug: HS-20094

HS-20094 (Multiple doses)

Experimental group

Description:

Escalating doses of HS-20094 administered SC once weekly for four weeks in healthy participants.

Treatment:

Drug: HS-20094

Placebo (Single dose)

Placebo Comparator group

Description:

Placebo administered SC once in healthy participants.

Treatment:

Drug: Placebo

Placebo (Multiple doses)

Placebo Comparator group

Description:

Placebo administered SC once weekly for four weeks in healthy participants.

Treatment:

Drug: Placebo