Study of SYH2062 Injection in Healthy Chinese Volunteers

CSPC Pharmaceutical Group

Status and phase

Enrolling

Phase 1

Conditions

Healthy Chinese Volunteers

Treatments

Drug: SYH2062-Matching placebo

Drug: SYH2062 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06842537

SYH2062-001

Details and patient eligibility

About

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

Full 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

Enrollment

46 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.