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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Chinese Volunteers
• Intervention / Treatment: Drug: SYH2062 injection; Drug: SYH2062-Matching placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wang Hongyun, Doctor; Phone Number: +8618611513192; Email: wanghy@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Chinese Academy of Medical Science and Peking Union Medical College Hospital
      • Contact: Wang Hongyun; Phone Number: +8618611513192; Email: wanghy@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent.
2. Age of 18 - 55 years (inclusive).
3. 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.
4. Has Systolic blood pressure (SBP) ≥100 mmHg and <140 mmHg and diastolic blood pressure (DBP) ≥60 mmHg and <90 mmHg at screening;
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYH2062 injection	Drug: SYH2062 injection; SYH2062 for sc injection
Placebo Comparator: SYH2062-Matching placebo	Drug: SYH2062-Matching placebo; Normal saline matching volume of SYH2062 doses will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events (AEs)	up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Blood Angiotensinogen (AGT) Level	up to approximately 12 months
Change from Baseline in in plasma renin concentration	up to approximately 12 months
Change from Baseline in in plasma renin activity	up to approximately 12 months
Change from Baseline in in angiotensin I	up to approximately 12 months
Change from Baseline in in angiotensin II	up to approximately 12 months
Change from Baseline in in plasma aldosterone	up to approximately 12 months
To characterize the Cmax of single dose of SYH2062	Up to Day 3
To characterize the AUC of single dose of SYH2062	Up to Day 3
Number of Participants With Anti- SYH2062 Antibodies	up to approximately 3 months

Collaborators and Investigators

• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SYH2062-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No