NL-OMON49945已完成不适用
A phase 1, randomized, double-blind, placebo-controlled, single-dose escalation, multiple-dose escalation, and food effect study of RPT193 in healthy subjects and patients with moderate to severe atopic dermatitis - RPT193 SAD, MAD and FE Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Part A and B:
- •- Sex: male or female
- •- Age: 18-55 years, inclusive, at the time of consent.
- •- Body mass index (BMI): 18.0*30.0 kg/m2 at screening.
- •- Weight: *50 kg.
- •- Status: healthy subjects
- •(Note: For Groups A5 and A6, the age range will be 18-54 years, inclusive, at
- •the time of consent to mitigate Coronavirus Disease 2019 [COVID-19] risks).
- •- Male or female patient aged 18 to 65 years, inclusive, at the time of consent.
- •- Patient has a body mass index *18 and *35 kg/m2 at screening.
- •- Patient has at least a 12-month history of AD and had no significant flares
- •in AD for at least 4 weeks before screening, as determined by the Investigator
- •through patient interview at the screening visit or information obtained from
- •medical chart or patient*s physician.
- •- Patient has clinically confirmed diagnosis of active AD, according to the
- •revised Hanifin and
- •Rajka criteria
排除标准
- •Part A and B:
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Participation in a
- •drug study within 60 days prior to (the first) drug administration in the
- •current study. Participation in more than 4 other drug studies in the 12 months
- •prior to (the first) drug administration in the current study.
- •Donation or loss of more than 100 mL of blood within 60 days prior to (the
- •first) drug
- •administration. Donation or loss of more than 1.5 liters of blood (for male
- •subjects) / more
- •than 1.0 liters of blood (for female subjects) in the 10 months prior to (the
- •first) drug
- •administration in the current study.
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS.
- •- Patient has a history of skin disease or presence of skin condition that, in
- •the opinion of the Investigator, would interfere with the study assessments.
- •Note: Fungal infection of nail beds is allowed.
- •- Patient who is still participating in a clinical trial or who has
- •participated in a clinical trial within 1 month prior to the Screening visit.
- •- Patient has used tanning beds or phototherapy (narrowband UVB [NBUVB], UV-B,
- •ultraviolet A1 [UVA1], or psoralen-UV-A [PUVA]) within 4 weeks prior to the
- •Baseline visit.
- •- Patient has received treatment with systemic immunosuppressive/
- •immunomodulating drugs (eg, methotrexate, cyclosporine A, or systemic Janus
- •kinase [JAK] inhibitors), immunoglobulins, blood products and/or systemic
- •corticosteroids (eg, oral, intravenous, intraarticular, rectal) within 4 weeks
- •prior to the Baseline visit. Note: Intranasal corticosteroids and inhaled
- •corticosteroids are allowed. Eye and ear drops containing corticosteroids are
- •also allowed.
- •- Patient has used any topical medicated treatment that could affect AD within
- •2 weeks prior to the Baseline visit, including, but not limited to, topical
- •corticosteroids, crisaborole, calcineurin inhibitors, tars, antimicrobials,
- •medical devices, and bleach baths.
研究者
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