NCT06553287已完成1 期
A Phase Ib, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 Ointment in Adults Patients With Mild to Moderate Atopic Dermatitis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Treatment-Emergent Adverse Events (TEAE)
研究概览
简要总结
The purpose of the study is to evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (BID) in Adults Patients with Atopic Dermatitis.
详细描述
This is a multicenter, randomized, double-blind, vehicle-controlled, dose-escalation study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment twice daily (BID) in participants with Mild to Moderate atopic dermatitis as compared with vehicle cream BID.
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
- •Participants were diagnosed with atopic dermatitis (AD) for at least 6 months.
- •Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
- •Participants with body surface area (BSA) of AD involvement, excluding the scalp, face, and intertriginous areas, of 3% to 20% at screening and baseline.
- •BMI of 18.0-30.0 kg/m2, with body weight ≥ 50 kg for man and ≥ 40 kg for woman.
- •Be willing to comply with the study lifestyle restraints, e.g., no washing of the administered area within 6 hours of study drug administration, no sweaty exercise.
排除标准
- •Participants with a physical condition which, in the Investigator´s opinion, might interfere with the assessment of atopic dermatitis or expose the patient to an unacceptable risk by study participation.
- •Participants with current evidence of any acute skin infection with a history of recurrent or chronic severe skin infection.
- •Participants with known allergies to components or excipients of the test drug.
- •Participants who are pregnant, nursing, or planning a pregnancy during the study period.
- •Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, mycophenolate mofetil, PDE4 inhibitor) used for atopic dermatitis within 4 weeks or 5 half-lives of baseline (whichever is longer).
- •Participants with the following hematologic abnormities at screening:
- •Leukocytes < 3.0 × 10^9/L.
- •Neutrophils < lower limit of normal.
- •Hemoglobin < 10 g/dL.
- •Lymphocytes < 0.8 × 10^9/L
- •Platelets < 100 × 10^9/L.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.
- •TBiL ≥ 1.5 × ULN, or ULN < TBiL < 1.5 × ULN but judged by the investigator to be abnormal clinically significant;
研究组 & 干预措施
LNK01004 ointment 0.3%
Experimental
Participants will receive LNK01004 ointment 0.3% twice daily
干预措施: LNK01004 ointment 0.3% (Drug)
LNK01004 ointment 1.0%
Experimental
Participants will receive LNK01004 ointment 1.0% twice daily
干预措施: LNK01004 ointment 1.0% (Drug)
LNK01004 ointment 1.5%
Experimental
Participants will receive LNK01004 ointment 1.5% twice daily
干预措施: LNK01004 ointment 1.5% (Drug)
Vehicle
Experimental
Participants will receive vehicle BID
干预措施: Vehicle BID (Drug)
结局指标
主要结局
Treatment-Emergent Adverse Events (TEAE)
时间窗: Baseline up to week 4
Number of participants with at least one TEAE.
次要结局
- Maximum concentration (Cmax) for LNK01004 in plasma(Day1 and Day 7)
- Area under plasma concentration versus time curve, time zero to infinity(Day 1 and Day7)
- Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score(Baseline and Weeks 1, 2, and 4)
- Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)(Baseline and Weeks 1, 2, and 4)
- Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score(Baseline and Weeks 1, 2, and 4)
- Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline(Baseline and Weeks 1, 2, and 4)
研究者
研究点 (1)
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