Clinical trial NCT06842537: Study of SYH2062 Injection in Healthy Chinese Volunteers
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2062 Injection in Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Chinese Volunteers
Lead sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: up to approximately 12 months
Secondary outcomes:
measure: Change from Baseline in Blood Angiotensinogen (AGT) Level
timeFrame: up to approximately 12 months
measure: Change from Baseline in in plasma renin concentration
timeFrame: up to approximately 12 months
measure: Change from Baseline in in plasma renin activity
timeFrame: up to approximately 12 months
measure: Change from Baseline in in angiotensin I
timeFrame: up to approximately 12 months
measure: Change from Baseline in in angiotensin II
timeFrame: up to approximately 12 months
measure: Change from Baseline in in plasma aldosterone
timeFrame: up to approximately 12 months
measure: To characterize the Cmax of single dose of SYH2062
timeFrame: Up to Day 3
measure: To characterize the AUC of single dose of SYH2062
timeFrame: Up to Day 3
measure: Number of Participants With Anti- SYH2062 Antibodies
timeFrame: up to approximately 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Science and Peking Union Medical College Hospital
state: Beijing
Study officials:
References: