Study of SYH2062 Injection in Healthy Chinese Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SYH2062 injection, SYH2062-Matching placebo.
- Who it may be relevant to
- Registry conditions: Healthy Chinese Volunteers. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2062 Injection in Healthy Chinese Volunteers
Overview
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
Interventions
- Drug SYH2062 injection
SYH2062 for sc injection - Drug SYH2062-Matching placebo
Normal saline matching volume of SYH2062 doses will be administered
Primary outcome measures
- Number of Participants with Adverse Events (AEs) [Time frame: up to approximately 12 months]
Secondary outcome measures (9)
- Change from Baseline in Blood Angiotensinogen (AGT) Level [Time frame: up to approximately 12 months]
- Change from Baseline in in plasma renin concentration [Time frame: up to approximately 12 months]
- Change from Baseline in in plasma renin activity [Time frame: up to approximately 12 months]
- Change from Baseline in in angiotensin I [Time frame: up to approximately 12 months]
- Change from Baseline in in angiotensin II [Time frame: up to approximately 12 months]
- Change from Baseline in in plasma aldosterone [Time frame: up to approximately 12 months]
- To characterize the Cmax of single dose of SYH2062 [Time frame: Up to Day 3]
- To characterize the AUC of single dose of SYH2062 [Time frame: Up to Day 3]
- Number of Participants With Anti- SYH2062 Antibodies [Time frame: up to approximately 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Science and Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06842537 · SYH2062-001