Trial of JYB1904 Injection in Adolescent Participants

Официальное название

A Multicenter, Single-arm, Phase Ib Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of JYB1904 Injection in Adolescent Participants Aged 12-17 Years

Обзор

This Phase Ib Trial is Meant to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of JYB1904 Injection in Adolescent Participants With Allergic Diseases.

Подробное описание

This Study is a multicenter, single-arm, Phase Ib clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of JYB1904 injection in adolescent participants aged 12-17 years

Вмешательства

• Препарат JYB1904
  Received a single 300 mg JYB1904 injection administered subcutaneously(SC) at D1

Первичные конечные точки

• Safety and Tolerability [Срок оценки: Through study completion, an average of 28 weeks]
• Pharmacokinetic (PK) profile of JYB1904 injection [Срок оценки: Through study completion, an average of 28 weeks]
• Pharmacokinetic (PK) profile of JYB1904 injection [Срок оценки: Through study completion, an average of 28 weeks]
• Pharmacokinetic (PK) profile of JYB1904 injection [Срок оценки: Through study completion, an average of 28 weeks]

Вторичные конечные точки (4)

• Other PK Parameters [Срок оценки: Through study completion, an average of 28 weeks]
• Other PK Parameters [Срок оценки: Through study completion, an average of 28 weeks]
• Pharmacodynamic (PD) profile of JYB1904 injection [Срок оценки: Through study completion, an average of 28 weeks]
• Immunogenicity of JYB1904 injection [Срок оценки: Through study completion, an average of 28 weeks]

Критерии участия

Критерии включения

• Adolescent study participants (both male and female) who are at least 12 years of age but under 18 years of age at the time of signing the Informed Consent Form (ICF).
• History of allergic diseases, including but not limited to food allergies, allergic rhinitis, allergic asthma, and chronic spontaneous urticaria.
• Body weight ≥ 30 kg at screening.
• Agreement to use effective contraception during the study and for 1 year following administration of the study drug.
• The trial participant and their parent or legal guardian are able to understand and voluntarily sign the Informed Consent Form, and are able to comply with study visits and related procedures.

Критерии исключения

• Patients with a history of hypersensitivity to JYB1904 Injection, its excipients, or any anti-IgE therapy.
• Any severe or poorly controlled chronic disease (including but not limited to severe arrhythmia, ischemic heart disease, NYHA Class III/IV left ventricular failure, severe pulmonary disease, poorly controlled asthma, poorly controlled hypertension, poorly controlled diabetes, or poorly controlled hypothyroidism or hyperthyroidism) that, in the investigator's judgment, may compromise the safety of the trial participant.
• History of severe allergic reactions, such as anaphylactic shock.
• History of blood phobia, needle phobia, or difficulty with venipuncture; or abnormal skin at the administration site that may interfere with drug administration or the investigator's assessment (e.g., skin lesions, rashes, tattoos, etc.).
• Total blood loss or blood donation of ≥400 mL within 12 weeks prior to screening, or receipt of a blood transfusion within 12 weeks prior to screening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07513857 · JYB1904-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗