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RecruitingPhase 1NCT06842537

Study of SYH2062 Injection in Healthy Chinese Volunteers

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2062 Injection in Healthy Chinese Volunteers

Sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Enrollment

46 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Chinese Volunteers

Summary

The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of SYH2062 injection in healthy Chinese volunteers

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

  • Subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent.
  • Age of 18 - 55 years (inclusive).
  • BMI: 19.0-26.0 kg/m\^2 (inclusive), with a minimum weight of 50 kg (inclusive) for males and 45 kg (inclusive) for females.
  • Has Systolic blood pressure (SBP) ≥100 mmHg and \<140 mmHg and diastolic blood pressure (DBP) ≥60 mmHg and \<90 mmHg at screening;
  • The subjects can communicate well with the investigators and complete the trial according to protocol.

Exclusion Criteria6

  • Allergic constitution, or known history of allergy to the components of the study drug or similar drugs.
  • Subjects with the following diseases of clinical significance (including but not limited to diseases of the circulatory system, diseases of the blood or hematopoietic system, diseases of the respiratory system, diseases of the endocrine system, diseases of the urinary system, diseases of the digestive system, neurological or mental diseases, infections, tumors, serious injuries).
  • Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.
  • Blood loss or blood donation of more than 200 mL within 3 months prior to initial administration (except for female menstrual period), and/or platelet donation within 2 weeks prior to initial administration.
  • Positive urine drug screening. 6 Those who smoked more than 5 cigarettes per day within 3 months prior to screening and/or did not agree to refrain from using any tobacco products during hospitalization.
  • Regular drinkers within 6 months prior to screening, i.e., those who drank more than 14 units of alcohol per week, and/or those who could not stop drinking alcohol during their hospitalization, and/or test positive for breath alcohol.
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Interventions

DRUGSYH2062 injection

SYH2062 for sc injection

DRUGSYH2062-Matching placebo

Normal saline matching volume of SYH2062 doses will be administered

Locations(1)

Chinese Academy of Medical Science and Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06842537