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NCT Number: NCT06842537

Study of SYH2062 Injection in Healthy Chinese Volunteers

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chinese Academy of Medical Science and Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Wang Hongyun

CONTACT

[email protected]

+8618611513192

About this study

A Phase 1, randomized, double-Blind, placebo-Controlled study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SYH2062 injection after a single administration in healthy subjects

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

Allergic constitution, or known history of allergy to the components of the study drug or similar drugs.

2 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).

3 Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.

4 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.

5 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.

7 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.

Treatment and study plan

SYH2062 injection

Drug

SYH2062 for sc injection

SYH2062-Matching placebo

Drug

Normal saline matching volume of SYH2062 doses will be administered

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: up to approximately 12 months

Secondary outcomes

  1. Change from Baseline in Blood Angiotensinogen (AGT) Level

    Time frame: up to approximately 12 months

  2. Change from Baseline in in plasma renin concentration

    Time frame: up to approximately 12 months

  3. Change from Baseline in in plasma renin activity

    Time frame: up to approximately 12 months

  4. Change from Baseline in in angiotensin I

    Time frame: up to approximately 12 months

  5. Change from Baseline in in angiotensin II

    Time frame: up to approximately 12 months

  6. Change from Baseline in in plasma aldosterone

    Time frame: up to approximately 12 months

  7. To characterize the Cmax of single dose of SYH2062

    Time frame: Up to Day 3

  8. To characterize the AUC of single dose of SYH2062

    Time frame: Up to Day 3

  9. Number of Participants With Anti- SYH2062 Antibodies

    Time frame: up to approximately 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Wang Hongyun, Doctor

CONTACT

[email protected]

+8618611513192

Sponsors and collaborators

Lead sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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