A Study of HS-20094 in Healthy Participants

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116410
• Other study ID #: HS-20094-101
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Yimin Cui, PhD
• Phone: 66110802
• Email: cuiymzy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• HS-20094
Administrated SC
• Placebo
Administrated SC

Locations

Country	Name	City	State
China	Beijing University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Cmax of HS-20094	PK: Cmax of HS-20094	Baseline to Day 22 (SAD) or Day 43 (MAD)
Secondary	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)
Secondary	Pharmacokinetics (PK): Tmax of HS-20094	PK: Tmax of HS-20094	Baseline to Day 22 (SAD) or Day 43 (MAD)
Secondary	Pharmacodynamics (PD): AUC of glucose	PD: AUC of glucose	Day 22 (MAD)
Secondary	Pharmacodynamics (PD): AUC of insulin	PD: AUC of insulin	Day 22 (MAD)
Secondary	Weight change		baseline to Day 29 (SAD) or Day 50 (MAD)