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A Bioequivalence Study of HS-20094 Multi-dose Pre-filled Injection and HS-20094 Single-dose Pre-filled Injection in Overweight or Obese Participants

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a multicenter, randomized, open-label, parallel clinical study to evaluate the bioequivalence of the HS-20094 MDV pen and AI pen in overweight or obese subjects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• Able to understand the procedures and methods of this study, willing to strictly adhere to the clinical study protocol to complete this study, and voluntarily sign the informed consent form;

• Adult male or female participants (aged 18-65 years (inclusive), calculated based on the date of signing the informed consent form);

• Body mass index (BMI) ≥24.0 kg/m2 (BMI = weight (kg) / height2 (m2)); body weigh ≥45 kg for female participants and ≥50 kg for male participants.

• Self-reported diet/exercise control alone for at least 12 weeks prior to screening, with a weight change of ≤5% in the past 12 weeks (based on self-report); calculation formula for weight change: (highest weight - lowest weight within 12 weeks prior to screening) ∕ highest weight \* 100%;

• Agree to take effective contraceptive measures from the signing of the informed consent form until 8 weeks after the last dose, and have no plans for conception or sperm/egg donation during this period (only non-drug contraceptive measures are permitted during the study).

Locations
Other Locations
China
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Contact Information
Primary
Yu Cao
caoyu1767@126.com
18661809090
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2026-05-29
Participants
Target number of participants: 144
Treatments
Experimental: T1 group
HS-20094 AI pen administered subcutaneously (SC) once a week.
Experimental: T2 group
HS-20094 MDV pen administered subcutaneously (SC) once a week.
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Hansoh Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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