NCT07318675招募中1 期
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
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月25日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The number and severity of treatment emergent adverse events (TEAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed as actinic keratosis by histopathology, with Olsen grade 1 or
- •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.
排除标准
- •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.
研究组 & 干预措施
HW211026
Experimental
Single or multiple topical doses of HW211026
干预措施: HW211026 (Drug)
Placebo
Placebo Comparator
Single or multiple topical doses of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The number and severity of treatment emergent adverse events (TEAEs)
时间窗: up to 28 days
To assess the safety and tolerability of single or multiple topical doses of HW211026 in adults with actinic keratosis
次要结局
- The time to reach Cmax(Tmax)(up to 10 days)
- The maximum serum concentration(Cmax)(up to 10 days)
- The Area Under the Curve from dosing to the time of the last measured concentration(up to 10 days)
- The Half life(t1/2)(up to 10 days)
研究者
研究点 (1)
Loading locations...
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