Clinical trial NCT05116410: A Study of HS-20094 in Healthy Participants
Official title: A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug
timeFrame: Time of Inform Consent Form to Day 29 (SAD) or Day 50 (MAD)
Secondary outcomes:
measure: Pharmacokinetics (PK): Cmax of HS-20094
timeFrame: Baseline to Day 22 (SAD) or Day 43 (MAD)
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094
timeFrame: Baseline to Day 22 (SAD) or Day 43 (MAD)
measure: Pharmacokinetics (PK): Tmax of HS-20094
timeFrame: Baseline to Day 22 (SAD) or Day 43 (MAD)
measure: Pharmacodynamics (PD): AUC of glucose
timeFrame: Day 22 (MAD)
measure: Pharmacodynamics (PD): AUC of insulin
timeFrame: Day 22 (MAD)
measure: Weight change
timeFrame: baseline to Day 29 (SAD) or Day 50 (MAD)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing University First Hospital
state: Beijing
Study officials:
affiliation: Beijing University First Hospital
name: Yimin Cui
role: PRINCIPAL_INVESTIGATOR
References: