A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.

Официальное название

A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW211026 Ointment After Single or Multiple Doses in Subjects With Actinic Keratosis

Обзор

This is a phase Ib study to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HW211026 ointment after single or multiple topical administrations in patients with actinic keratosis.

Вмешательства

• Препарат HW211026
  Dose 1 and Dose 2
• Препарат Placebo
  Dose 1 and Dose 2

Первичные конечные точки

• The number and severity of treatment emergent adverse events (TEAEs) [Срок оценки: up to 28 days]

Вторичные конечные точки (4)

• The maximum serum concentration(Cmax) [Срок оценки: up to 10 days]
• The Area Under the Curve from dosing to the time of the last measured concentration [Срок оценки: up to 10 days]
• The time to reach Cmax(Tmax) [Срок оценки: up to 10 days]
• The Half life(t1/2) [Срок оценки: up to 10 days]

Критерии участия

Критерии включения

• Confirmed as actinic keratosis by histopathology, with Olsen grade 1 or 2.
• A 100 cm² treatment field can be demarcated on the face, which covers clinically typical actinic keratosis lesions (excluding lesions on the lips, perioral region, eyelids, periorbital area, inside and around the nostrils, and the inner ear canal).
• Willing to avoid direct exposure of the treatment field to sunlight or ultraviolet (UV) radiation during the study.

Критерии исключения

• Subjects with any of the following conditions within the treatment field：

• Presence of clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns;
• Maximum diameter of a single lesion > 2 cm；
• History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors；
• Presence of other skin diseases or conditions that may cause difficulties in examination or evaluation.
• treatment field falls within any of the following locations:

• Presence of incompletely healed wounds within a 5 cm radius of the treatment field;
• Presence of suspected squamous cell carcinoma, basal cell carcinoma, or other tumors within a 5 cm radius of the treatment field.
• Subjects with other skin diseases (e.g., atopic dermatitis, psoriasis, eczema, etc.) or other skin conditions (e.g., tattoos, birthmarks, ulcerations, scars, open wounds, etc.) that the investigator deems may interfere with the assessment of safety or efficacy.
• Subjects with severe cardiovascular and cerebrovascular diseases.
• Receipt of any systemic drug therapy for actinic keratosis within 6 months prior to screening.
• Receipt of any topical intervention for actinic keratosis on the administration area within 3 months prior to screening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Skin Disease Hospital — Шанхай

Идентификаторы

NCT: NCT07318675 · HW211026-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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