A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Dose Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-6194 in Participants With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 19
- 主要终点
- Number of Participants Who Experience One or More Adverse Events (AEs)
研究概览
简要总结
The primary objective of this study is to characterize the safety and tolerability of MK-6194 following multiple doses among participants with moderate to severe atopic dermatitis who are unresponsive to other therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of atopic dermatitis for at least 6 months prior to the Screening visit.
- •Atopic dermatitis is of at least moderate severity.
- •History of inadequate response to a stable (≥1 month) regimen of medium to high potency topical corticosteroids or calcineurin inhibitors as treatment for atopic dermatitis within 6 months before the screening visit.
- •Body Mass Index (BMI) ≥18 and ≤38 kg/m2 at the screening visit.
排除标准
- •Concurrent significant skin disease other than atopic dermatitis (such as psoriasis) or a concurrent clinically significant disease.
- •Significant organ dysfunction that is unstable or inadequately treated within 6 months prior to Screening.
- •History of cancer (malignancy), with the exceptions: of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or; other malignancies that have been successfully treated with appropriate follow up.
- •History of myocardial infarction, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of Screening.
- •History of organ or tissue allograft.
- •History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system (CNS) zoster.
- •Major surgery within 3 months prior to the screening visit or has a major surgery planned during the study.
- •Received a live or attenuated virus vaccine within 4 weeks prior to the Screening visit or intends to receive live or attenuated virus vaccination during the course of the study and for 12 weeks after the last dose of study drug.
- •Currently receiving any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
研究组 & 干预措施
Expansion Dose F
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.
干预措施: Placebo (Biological)
Dose Escalation Panel A
Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).
干预措施: MK-6194 (Biological)
Dose Escalation Panel A
Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).
干预措施: Placebo (Biological)
Dose Escalation Panel B
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
干预措施: MK-6194 (Biological)
Dose Escalation Panel B
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
干预措施: Placebo (Biological)
Dose Escalation Panel C
Participants are randomized to high dose MK-6194 or placebo administered q2w.
干预措施: MK-6194 (Biological)
Dose Escalation Panel C
Participants are randomized to high dose MK-6194 or placebo administered q2w.
干预措施: Placebo (Biological)
Expansion Panel D
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
干预措施: MK-6194 (Biological)
Expansion Panel D
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
干预措施: Placebo (Biological)
Expansion Panel E
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.
干预措施: MK-6194 (Biological)
Expansion Panel E
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.
干预措施: Placebo (Biological)
Expansion Dose F
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.
干预措施: MK-6194 (Biological)
结局指标
主要结局
Number of Participants Who Experience One or More Adverse Events (AEs)
时间窗: Up to approximately 169 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
Number of Participants Who Discontinue Study Intervention Due to an AE
时间窗: Up to approximately 85 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study intervention due to an AE is presented.
次要结局
- Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194(Day 1 (Predose and 12 hours postdose), Day 8, and Day 15)
- AUC From Days 29-43 (AUC29-43) of MK-6194(Day 29 (Predose and 12 hours postdose), Day 36, and Day 43)
- Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)(Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose))
- Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)(Predose on Days 15 and 29)
- Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)(Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose))
- Geometric Mean Accumulation Ratio of AUC of MK-6194(Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43)
- Geometric Mean Accumulation Ratio of Cmax of MK-6194(Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43)
- Fold Change From Baseline in Peak Regulatory T Cells (Tregs)(Baseline and Day 85)