Study of SYH2062 Injection in Healthy Chinese Volunteers

Официальное название

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2062 Injection in Healthy Chinese Volunteers

Обзор

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

Подробное описание

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

Вмешательства

• Препарат SYH2062 injection
  SYH2062 for sc injection
• Препарат SYH2062-Matching placebo
  Normal saline matching volume of SYH2062 doses will be administered

Первичные конечные точки

• Number of Participants with Adverse Events (AEs) [Срок оценки: up to approximately 12 months]

Вторичные конечные точки (9)

• Change from Baseline in Blood Angiotensinogen (AGT) Level [Срок оценки: up to approximately 12 months]
• Change from Baseline in in plasma renin concentration [Срок оценки: up to approximately 12 months]
• Change from Baseline in in plasma renin activity [Срок оценки: up to approximately 12 months]
• Change from Baseline in in angiotensin I [Срок оценки: up to approximately 12 months]
• Change from Baseline in in angiotensin II [Срок оценки: up to approximately 12 months]
• Change from Baseline in in plasma aldosterone [Срок оценки: up to approximately 12 months]
• To characterize the Cmax of single dose of SYH2062 [Срок оценки: Up to Day 3]
• To characterize the AUC of single dose of SYH2062 [Срок оценки: Up to Day 3]
• Number of Participants With Anti- SYH2062 Antibodies [Срок оценки: up to approximately 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese Academy of Medical Science and Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT06842537 · SYH2062-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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