A Study of HS-20094 in Healthy Participants

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: HS-20094

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yimin Cui, PhD; Phone Number: 010 66110802; Email: cuiymzy@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 110000
      • Recruiting
      • Beijing University First Hospital
      • Contact: Yimin Cui, PhD; Phone Number: 010 66110802; Email: cuiymzy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HS-20094 (Single dose); Escalating doses of HS-20094 administered subcutaneously (SC) once in healthy participants.	Drug: HS-20094; Administrated SC; Other Names: HS-20094 injection
EXPERIMENTAL: HS-20094 (Multiple doses); Escalating doses of HS-20094 administered SC once weekly for four weeks in healthy participants.	Drug: HS-20094; Administrated SC; Other Names: HS-20094 injection
PLACEBO_COMPARATOR: Placebo (Single dose); Placebo administered SC once in healthy participants.	Drug: Placebo; Administrated SC; Other Names: Placebo injection
PLACEBO_COMPARATOR: Placebo (Multiple doses); Placebo administered SC once weekly for four weeks in healthy participants.	Drug: Placebo; Administrated SC; Other Names: Placebo injection

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yimin Cui, Beijing University First Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ANTICIPATED): October 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (ACTUAL): November 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HS-20094-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No