Идёт набор NCT07245368

Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma

Фаза I / Фаза II С лечением Mild to Moderate Asthma

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: PRA-216, Placebo.
Кому может быть актуально: Состояния в реестре: Mild to Moderate Asthma. Базовые параметры: 18 лет — 65 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: Австралия, Новая Зеландия
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, Double-Blind, Placebo-Controlled, Single Ascending and Multiple Ascending Dose Study Investigating PRA-216 in Healthy Volunteers Followed by a Phase 2a Randomized, Double-Blind, Placebo-Controlled Study in Participants With Mild-to-Moderate Asthma

Обзор

Phase 1 of this study will consist of 2 parts * Part 1 will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 in healthy volunteers through single ascending dose administered by either intravenous (IV) or subcutaneous (SC). * Part 2 will evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of PRA-216 in healthy volunteers with repeat doses of multiple ascending dose administered subcutaneously. Phase 2a of this study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity of PRA-216 in participants with mild to moderate asthma. The dose of PRA-216 for this phase was determined from Phase 1.

Подробное описание

This study is a Phase 1/2a randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy participants and participants with mild to moderate asthma. Single-ascending dose (SAD) cohorts will be evaluated for one single dose administered. Multiple ascending dose (MAD) cohorts will be evaluated for repeat doses .

Participants with mild to moderate asthma will be recruited for Phase 2a of this study, to evaluate safety of randomized, double blind, placebo controlled PRA-216. The dose of PRA-216 for this phase was determined from Phase 1 safety, tolerability, and PK data. Additional dose levels or schedules may be used for Phase 2a, depending on data from Phase 1.

This study consists of 2 phases, as follows:

Phase 1, Part 1:

SAD in healthy volunteers. Study visits in this section will entail a single dose administration of PRA-216 or placebo and collection of study data.

Phase 1, Part 2:

MAD in healthy volunteers. Study visits in this section will entail repeat doses of PRA-216 or placebo and collection of study data.

Phase 2a Participants with mild to moderate asthma will receive PRA-216 or placebo.

Вмешательства

Препарат PRA-216
biologic
Препарат Placebo
matching placebo for PRA-216

Первичные конечные точки

Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm) [Срок оценки: Up to Study Day 169]
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) of multiple doses of PRA-216 in healthy volunteers (MAD arm) [Срок оценки: up to Study Day 169]
Phase 2a: To evaluate the effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in asthma participants [Срок оценки: Up to Study Day 57]

Вторичные конечные точки (9)

Phase 1: Immunogenicity of PRA-216: ADA in healthy volunteers [Срок оценки: Up to Study Day 169]
Phase 1: Pharmacokinetics of PRA-216: Tmax in healthy volunteers [Срок оценки: Up to Study Day 169]
Phase 1: Pharmacokinetics of PRA-216: AUC in healthy volunteers [Срок оценки: Up to Study Day 169]
Phase 1: Pharmacokinetics of PRA-216: Cmax in healthy volunteers [Срок оценки: Up to Study Day 169]
Phase 2a: Incidence, nature, and severity of serious adverse events (SAEs) of PRA-216 in patients with asthma [Срок оценки: Up to Study Day 197]
Phase 2a: Immunogenicity of PRA-216: ADA in patients with asthma [Срок оценки: Up to Study Day 197]
Phase 2a: Pharmacokinetics of PRA-216: Tmax in patients with asthma [Срок оценки: Up to Study Day 197]
Phase 2a: Pharmacokinetics of PRA-216: AUC in patients with asthma [Срок оценки: Up to Study Day 197]
Phase 2a: Pharmacokinetics of PRA-216: Cmax in patients with asthma [Срок оценки: Up to Study Day 197]

Критерии участия

Phase 1

Критерии включения

Age 18-65
Must be in good health with no significant medical history
Willing and able to attend all study visits, comply with study requirements
Able and willing to provide written informed consent

Критерии исключения

Evidence of clinically significant condition or disease
Any physical or psychological condition that prohibits study completion
Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
History of severe allergic reactions or hypersensitivity
Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing

Phase 2a

Критерии включения

Age 18-65
Must be in good health with no significant medical history
Willing and able to attend all study visits, comply with study requirements.
Able and willing to provide written informed consent
Documented asthma diagnosis prior for at least 12 months prior to screening.
Symptomatic asthma
Currently receiving maintenance asthma medications

Критерии исключения

Evidence of clinically significant condition or disease
Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing
History of severe allergic reactions or hypersensitivity
Current or former smoker with a smoking history of ≥10 pack-years
Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening
Other investigational agent(s) within 30 days of dosing

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

Здоровые добровольцы: Да