A Study of HS-20094 in Healthy Participants

NCT05116410 | Unknown Phase 1

• 1 other identifier: HS-20094-101
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pharmacokinetics (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

  Baseline to Day 22 (SAD) or Day 43 (MAD)

• Pharmacokinetics (PK): Tmax of HS-20094

  Baseline to Day 22 (SAD) or Day 43 (MAD)

• Pharmacodynamics (PD): AUC of glucose

  Day 22 (MAD)

• Pharmacodynamics (PD): AUC of insulin

  Day 22 (MAD)

Study Arms (4)

HS-20094 (Single dose)

EXPERIMENTAL

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

Drug: HS-20094

HS-20094 (Multiple doses)

EXPERIMENTAL

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

Drug: HS-20094

Placebo (Single dose)

PLACEBO COMPARATOR

Placebo administered SC once in healthy participants.

Drug: Placebo

Placebo (Multiple doses)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

HS-20094 DRUG

Administrated SC

Also known as: HS-20094 injection

HS-20094 (Multiple doses); HS-20094 (Single dose)

Placebo DRUG

Administrated SC

Also known as: Placebo injection

Placebo (Multiple doses); Placebo (Single dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing University First Hospital

Beijing, Beijing Municipality, 110000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yimin Cui

  Beijing University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yimin Cui, PhD

CONTACT

66110802; cuiymzy@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 11, 2021
• Study Start: November 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 19, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)