A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults

Обзор

A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults

Вмешательства

• Препарат SHR-7012 injection ; placebo
  A single subcutaneous injection of Dose1 SHR-7012 injection or placebo was administered
• Препарат SHR-7012 injection ; placebo
  A single subcutaneous injection of Dose2 SHR-7012 injection or placebo was administered
• Препарат SHR-7012 injection ; placebo
  A single subcutaneous injection of Dose3 SHR-7012 injection or placebo was administered
• Препарат SHR-7012 injection ; placebo
  A single subcutaneous injection of Dose4 SHR-7012 injection or placebo was administered
• Препарат SHR-7012 injection ; placebo ;
  A single subcutaneous injection of Dose5 SHR-7012 injection or placebo was administered

Первичные конечные точки

• Safety and tolerability : Incidence and severity of any adverse events [Срок оценки: Evaluation was performed up to Day141]

Вторичные конечные точки (12)

• AUC0-t [Срок оценки: Evaluation was performed up to Day113 or Day141]
• AUC0 ∞ [Срок оценки: Evaluation was performed up to Day113 or Day141]
• Tmax [Срок оценки: Evaluation was performed up to Day113 or Day141]
• Cmax [Срок оценки: Evaluation was performed up to Day113 or Day141]
• t1/2 [Срок оценки: Evaluation was performed up to Day113 or Day141]
• λz [Срок оценки: Evaluation was performed up to Day113 or Day141]
• CL/F [Срок оценки: Evaluation was performed up to Day113 or Day141.]
• Vz/F [Срок оценки: Evaluation was performed up to Day113 or Day141.]
• MRT0-t [Срок оценки: Evaluation was performed up to Day113 or Day141.]
• MRT0-∞ [Срок оценки: Evaluation was performed up to Day113 or Day141.]
• AUC%Extrap [Срок оценки: Evaluation was performed up to Day113 or Day141.]
• Antidrug antibody (ADA) [Срок оценки: Evaluation was performed up to Day113 or Day141.]

Критерии участия

Критерии включения

• The age of signing the informed consent form was between 18 and 55 years old (inclusive), both male and female.
• Body weight ≥50 kg for men and ≥45 kg for women during the screening period, body mass index (BMI = weight (kg)/ height 2(m2)) between 19.0 and 26.0 kg/m2 (including boundary value)
• Female participants of childbearing potential and male participants whose partners were fertile women had no plans to give birth, sperm or egg donation within 6 months after signing the informed consent, and voluntarily took highly effective contraceptive methods. Female participants of childbearing potential had to have a serum pregnancy test with a negative result during the screening and baseline periods
• Female participants: not pregnant or lactatin
• Before the trial, the participants had understood the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial in detail, were able to understand the procedures and methods of the study, were willing to strictly abide by the requirements of the entire clinical study, and voluntarily signed informed consent

Критерии исключения

• Patients with previous or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic disorders, who were judged by the investigator to be unsuitable for enrollment
• Patients had a history of severe herpesvirus infection, a history of malignancy, or current active infection
• Patients with chronic or recurrent infection requiring treatment within 12 months before screening
• A screening test for tuberculosis infection (interferon-γ release assay, IGRA) was positive
• There was a previous history of risk factors for torsades de pointes
• Patients who had undergone major surgery within 6 months before screening
• Persons who had been vaccinated within 1 month before screening or planned to be vaccinated during the trial
• Anyone who had taken any medication or health product (including Chinese herbal medicine) within 7 half-lives or 14 days before dose, whichever was longer, or who had known during the screening period that they might need to receive additional medication during the trial
• Participants who had participated in a clinical trial and received a trial drug within 3 months before screening or who planned to participate in another clinical trial during the trial
• Patients were screened if they had donated or lost at least 400 mL of blood (except physiological blood loss in women) within 3 months before the trial, received a transfusion or used blood products, or were planning to donate blood during or within 1 month after the trial
• People who have special dietary requirements and cannot follow a uniform diet
• Those with a history of drug abuse, drug use, or a positive screening test for drug abuse
• Those who have difficulty in venous blood collection/cannot tolerate venipuncture, or have a history of fainting or fainting
• If the site of administration was abnormal, the investigator judged that subcutaneous administration was not suitable
• Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhejiang Provincial People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT07749651 · SHR-7012-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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