Идёт набор NCT06989840

Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne

Фаза I С лечением Acne

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: TVB-3567, Placebo.
Кому может быть актуально: Состояния в реестре: Acne. Базовые параметры: 18 лет — 55 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: США, Австралия
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 and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TVB-3567 in Healthy Participants With or Without Acne and to Assess the Effect of Food in Healthy Participants

Обзор

This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be a randomized, open-label, 2-way crossover investigation to assess the effect of food on a single dose TVB-3567 administered orally in healthy participants. Parts C and D will be randomized, double-blind, placebo-controlled investigations of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants without and with moderate to severe acne, respectively.

Вмешательства

Препарат TVB-3567
Orally administered capsule
Препарат Placebo
Orally administered capsule

Первичные конечные точки

Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Baseline to 7 to 8 days after dosing]
Part B - Plasma AUC0-t in fasted and fed conditions [Срок оценки: Baseline to Day 4]
Part B - Plasma AUC0-inf in fasted and fed conditions [Срок оценки: Baseline to Day 4]
Part B - Plasma Cmax in fasted and fed conditions [Срок оценки: Baseline to Day 4]
Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions [Срок оценки: Baseline to 7 to 8 days after dosing]
Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Baseline to 13 to 15 days after the last dose]
Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Baseline to 13 to 15 days after the last dose]

Критерии участия

Критерии включения

Healthy Participants (Parts A, B and C)

Healthy, adult, male or female 18-55 years of age
Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2
Medically healthy with no clinically significant medical history
Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol

Healthy Participants with Acne (Part D only)

Participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study:

BMI ≥18.0 and ≤37.0 kg/m2.
Must be diagnosed with moderate to severe acne vulgaris

Критерии исключения

Healthy Participants (Parts A, B and C)

History or presence of clinically significant medical or psychiatric condition or disease
History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products.
Has a clinically significant ophthalmic examination finding
Female participant of childbearing potential
Unable to refrain from or anticipates the use of:

Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements
Any topical anti-acne treatment on the face
Any drugs known to be moderate or strong inducers of CYP3A4 enzymes, BCRP, and/or P gp, including St. John's Wort, beginning 28 days prior to the first dosing.
Part C only: Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all-trans retinoic acid.

Healthy Participants with Acne (Part D only)

Participants must not be enrolled if they do not meet any of the above criteria, as well as the following exclusion criteria:

Unable to refrain from or anticipates the use of:

Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all trans retinoic acid.
Photoelectric therapy, dermabrasion, or chemical peeling
Intra-articular and systemic corticosteroid therapy
Significant skin diseases

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

Здоровые добровольцы: Да