Study of SYH2062 Injection in Healthy Chinese Volunteers

NCT06842537 | Recruiting Phase 1

• 1 other identifier: SYH2062-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Chinese Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  up to approximately 12 months

Secondary Outcomes (9)

• 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

Study Arms (2)

SYH2062 injection

EXPERIMENTAL

Drug: SYH2062 injection

SYH2062-Matching placebo

PLACEBO COMPARATOR

Drug: SYH2062-Matching placebo

Interventions

SYH2062 injection DRUG

SYH2062 for sc injection

SYH2062 injection

SYH2062-Matching placebo DRUG

Normal saline matching volume of SYH2062 doses will be administered

SYH2062-Matching placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Chinese Academy of Medical Science and Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Wang Hongyun, Doctor

CONTACT

+8618611513192; wanghy@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-02

Locations

CN (1)