A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

Официальное название

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study of Single Subcutaneous Injections of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

Обзор

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study of Single Subcutaneous Injections of LBL-047 in Healthy Adults and Patients with systemic lupus erythematosus.

Подробное описание

This is a double-blind, randomized, placebo-controlled Phase I study to evaluate the safety, tolerability, PK, PD and immunogenicity of a single subcutaneous injection of LBL-047 in healthy adults and patients with systemic lupus erythematosus,the preliminary clinical efficacy of LBL-047 will also be evaluated in patients with systemic lupus erythematosus.

The study is divided into two parts.

Part A:Conduct studies in healthy adults.Part A is planned to be set up with 7 escalating dose groups.Participants were randomized to receive a single subcutaneous injection of LBL-047 or placebo.Dose escalation will be decided by the Safety Monitoring Committee (SMC).

Part B:Study in adult patients with systemic lupus erythematosus.Part B will be initiated at the dose levels that were confirmed to be safe and tolerable in Part A.Part B is planned to enroll patients with mild to moderate systemic lupus erythematosus and receive a single subcutaneous injection of LBL-047.

This study is expected to enroll 76 participants (with possible addition of 36 participants).

Вмешательства

• Препарат LBL-047 for Injection
  Single subcutaneous injection
• Препарат LBL-047 placebo for injection
  Single subcutaneous injection

Первичные конечные точки

• Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE) [Срок оценки: From first dose until last visit(within 85 days after drug injection)]

Вторичные конечные точки (4)

• Cmax [Срок оценки: From first dose until last visit(within 85 days after drug injection)]
• Tmax [Срок оценки: From first dose until last visit(within 85 days after drug injection)]
• Immunogenicity [Срок оценки: From first dose until last visit(within 85 days after drug injection)]
• Assessment of Pharmacodynamics [Срок оценки: From first dose until last visit(within 85 days after drug injection)]

Критерии участия

Критерии включения

• Voluntarily sign and date the informed consent form (ICF) and be willing and able to comply with the scheduled visits, treatment plan, laboratory test, and other study procedures.
• Age ≥ 18 and ≤ 60 years at the time of signing the ICF.
• Part A:Determined by the investigator to be in good health at the time of signing the ICF.
• Part B:Mild to moderate systemic lupus erythematosus: SLEDAI-2K score ≥4 and ≤ 10 at screening.
• Females of childbearing potential are willing to use highly effective contraception during the study and for 6 months after administration of the study drug and to avoid egg donation.Women of non-childbearing potential include: those with documented surgical sterilization or documented menopause.
• Male of childbearing potential are willing to use highly effective contraception during the study and for 6 months after study drug administration and to avoid sperm donation.Men without fertility potential include those with: A semen sample investigation that confirms azoospermia, definitive evidence of infertility, or a history of vasoligation.For the purpose of this study, men with a "low sperm count" (or "subfertility") are not considered infertile.

Критерии исключения

• Part A:Symptoms or history of any significant disease, including but not limited to cardiovascular, hepatic, renal or any other disease that may interfere with the study results.
• Part A:Abnormalities with clinical significance were indicated by vital signs, physical examination, laboratory test, 12-lead electrocardiogram (ECG), chest X-ray, and abdominal ultrasound.
• Part B:History of organ transplant or hematopoietic stem cell/bone marrow transplant.
• Part B:currently receiving treatment for any chronic infection (such as pneumocystosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteriosis).
• Major surgery (as judged by the investigator) within 90 days prior to dosing, or surgery scheduled during the study.
• At screening, women of childbearing potential were positive for pregnancy.follicle stimulating hormone (FSH) did not reach postmenopausal level in postmenopausal women (defined as amenorrhoea ≥ 12 months before screening).
• Large tattoo, scar or other condition that may interfere with assessment at the injection site.
• unable to tolerate venipuncture, difficulty in blood collection or has a history of needle/blood phobic disorder.
• The investigator determines that there are other conditions unsuitable for participation in this study.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 11 центров

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу
• Xiangya School of Medicine of Central South University — Чанша
• Nanjing Drum Tower Hospital — Нанкин
• Pingxiang People's Hospital — Pingxiang
• Shanghai JiaoTong University School of Medicine，Renji Hospital — Шанхай
• Shanghai Public Health Clinical Center — Шанхай
• Shanxi Bethune Hospital — Taiyuan
• … и ещё 3 центра

Идентификаторы

NCT: NCT07323173 · LBL-047-CN001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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