A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.

Официальное название

A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.

Обзор

The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.

Вмешательства

• Препарат SV003
  SV003：Single-dose
• Препарат Placebo
  Placebo ： Single-dose

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Approximately 3 months]

Вторичные конечные точки (5)

• Peak Plasma Concentration (Cmax) [Срок оценки: Approximately 3 months]
• Peak time（Tmax） [Срок оценки: Approximately 3 months]
• Area under the plasma concentration versus time curve (AUC) [Срок оценки: Approximately 3 months]
• half-life（T1/2） [Срок оценки: Approximately 3 months]
• Immunogenicity [Срок оценки: Approximately 3 months]

Критерии участия

Критерии включения

• Body Mass Index (BMI): 18.5 ≤ Chinese participants ≤ 30 kg/m², 18.5 ≤ Caucasian participants ≤ 32 kg/m²; additionally, male participants must have a body weight ≥ 50 kg, and female participants ≥ 45 kg;
• Healthy status: No evidence of active or chronic diseases in participants;
• Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.

Критерии исключения

• Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases;
• Subjects who have experienced a serious disease within 1 month prior to drug administration, or with any disease that may relapse immediately during or after the study;
• Subjects with designated examination results reaching a specified value;
• Subjects with abnormal laboratory test results deemed clinically significant by the investigator;
• Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody;
• Subjects with a history of drug abuse within the past 2 years, or with a positive urine drug screen on Day -1;
• Subjects with a history of alcohol dependence within the past 2 years, or with a positive breath alcohol test result on Day -1;
• Subjects with an average daily cigarette consumption of ≥ 5 cigarettes within 3 months prior to screening;
• Subjects who have donated blood or lost blood ≥ 400 mL within 3 months prior to drug administration, or donated blood or lost blood ≥ 200 mL within 1 month, or with a history of blood product use;
• Subjects with an allergic constitution, or with a history of allergy to the study drug, drugs of the same class or excipients;
• Subjects who have participated in clinical studies of investigational drugs or medical devices within 3 months prior to drug administration;
• Female subjects with a positive pregnancy test during the screening period or on Day -1, or who are breastfeeding;
• Chinese female subjects who are postmenopausal or have an irregular menstrual cycle;
• Female subjects of childbearing potential, or male subjects whose female partners are of childbearing potential, who refuse to adopt reliable contraceptive measures during the study and for 6 months after the last drug administration;
• Any other factors that the investigator deems may render a subject unsuitable for study participation.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Xuhui Central Hospital — Шанхай

Идентификаторы

NCT: NCT07469085 · SV003-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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