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Идёт набор NCT07471932

A Study of LAD106 in Healthy Adult Participants

Фаза I С лечением Healthy Volunteers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: LAD106, Lebrikizumab, Placebo.
Кому может быть актуально
Состояния в реестре: Healthy Volunteers. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1, Randomized, Two-part, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacodynamics of LAD106 in Healthy Adult Participants

Обзор

The main aim of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of single ascending doses of LAD106 (Part A) and multiple ascending doses of LAD106 (Part B) in human healthy participants.

Подробное описание

This is a 2-part study. Part A will comprise up to 6 cohorts of healthy adult participants and investigate single ascending doses of LAD106. Part B will comprise up to 3 cohorts of healthy adult participants to evaluate multiple ascending doses of LAD106, and 1 cohort will investigate the pharmacodynamic effects of lebrikizumab. The study is based on sequential cohorts for escalation of single and multiple doses of LAD106, where progression to the next cohort is only started following a review of safety, tolerability, and pharmacokinetic data of earlier study cohorts.

Вмешательства

  • Препарат LAD106
    LAD106 will be administered.
  • Препарат Lebrikizumab
    Lebrikizumab will be administered.
  • Другое Placebo
    Placebo matching LAD106 will be administered.

Первичные конечные точки

  • Part A (SAD): Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs [Срок оценки: From start of study drug up to follow-up (Day 81)]
  • Part B (MAD): Number of Participants with TEAEs and Severity of TEAEs [Срок оценки: From start of study drug up to follow-up (Day 104)]
Вторичные конечные точки (8)
  • Part A (SAD) and B (MAD): LAD106 Serum Concentrations Over Time [Срок оценки: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD]
  • Part A (SAD) and B (MAD): Maximum Serum Concentration (Cmax) of LAD106 [Срок оценки: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD]
  • Part A (SAD) and B (MAD): Time to Reach Maximum Serum Concentration (tmax) of LAD106 [Срок оценки: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD]
  • Part A (SAD) and B (MAD): Area Under the Serum Concentration-time Curve (AUC) of LAD106 [Срок оценки: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD]
  • Part A (SAD) and B (MAD): Elimination Half-life (t½) of LAD106 [Срок оценки: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD]
  • Part A (SAD): Absolute Bioavailability of LAD106 [Срок оценки: Up to Day 78]
  • Part A (SAD) and B (MAD): Number of Participants with Anti-drug Antibodies (ADA) Positive Samples [Срок оценки: Pre-dose up to Day 78 for SAD and up to Day 99 for MAD]
  • Part A (SAD) and B (MAD): Titer of Confirmed ADA Positive Samples [Срок оценки: Pre-dose up to Day 78 for SAD and up to Day 99 for MAD]

Критерии участия

Критерии включения

  • Signed informed consent and willing and able to comply with the study protocol.
  • Healthy men or women,18 to 45 years of age (inclusive) at screening.
  • Female participants agree to use effective contraception.
  • Male volunteers agree to use barrier protection when they engage in sexual relations with women of child-bearing potential (WOCBP) or lactating women.
  • Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m\^2), inclusive, and with a minimum bodyweight of 50 kg.
  • Has the ability to communicate well with the Investigator in Dutch language and willing to comply with the study restrictions.

Критерии исключения

  • Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the participant in the opinion of the investigator.
  • Clinically significant abnormalities, as judged by the Investigator, in laboratory test results.
  • Use of any medications (prescription or over-the-counter \[OTC\]), within 14 days prior to IMP dosing or less than 5 half-lives (whichever is longer). An exception is made for paracetamol (up to 4 g/day).
  • If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Нидерланды · 1 центр
  • Centre for Human Drug Research (CHDR) Phase 1 Unit — Leiden

Идентификаторы

NCT: NCT07471932 · M-27312-01 · 2025-523328-31-00 · CHDR2521

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗