Study of SYH2062 Injection in Healthy Chinese Volunteers

NCT ID: NCT06842537

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-31

Brief Summary

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

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

Conditions

Healthy Chinese Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SYH2062 injection

Group Type: EXPERIMENTAL

SYH2062 injection

Intervention Type: DRUG

SYH2062 for sc injection

SYH2062-Matching placebo

Group Type: PLACEBO_COMPARATOR

SYH2062-Matching placebo

Intervention Type: DRUG

Normal saline matching volume of SYH2062 doses will be administered

Interventions

SYH2062 injection

SYH2062 for sc injection

Intervention Type: DRUG

SYH2062-Matching placebo

Normal saline matching volume of SYH2062 doses will be administered

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese Academy of Medical Science and Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Hongyun, Doctor

Role: CONTACT

wanghy@pumch.cn

+8618611513192

Facility Contacts

Wang Hongyun

Role: primary

wanghy@pumch.cn

+8618611513192

Other Identifiers

SYH2062-001

Identifier Type: -

Identifier Source: org_study_id