NCT07527923招募中1 期
A Two-Part Phase 1, Randomized, Double-Blind, Placebo-Controlled First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN20423 in Adult Healthy Participants and Adult Participants With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Occurrence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans.
The study is looking at:
- What side effects REGN20423 might cause
- How much REGN20423 is in the blood at different times
- How well REGN20423 works in adults with atopic dermatitis
- Whether the body makes antibodies against REGN20423
- How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others
- What the best dose of REGN20423 is
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis
- •Key Inclusion Criteria:
- •Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention
- •Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit
- •Has a history of AD for at least 6 months at screening
- •Has EASI score ≥5 at both the screening and baseline visits
- •Has IGA score ≥2 at both the screening and baseline visits
排除标准
- •Hospitalized (>24 hours) for any reason within 30 days prior to the screening visit
- •Hypersensitivity to the study treatment or any of its excipients
- •History of clinical parasite infection, except treated trichomoniasis
- •Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study
- •History of alcohol or drug abuse as determined by the investigator
- •Known or suspected history of immunosuppression
- •Presence of skin comorbidities at screening that may interfere with study assessments
- •Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list
- •Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study
- •Note: Other protocol defined Inclusion/ Exclusion criteria apply
研究组 & 干预措施
Part A
Experimental
干预措施: REGN20423 (Drug)
Part A
Experimental
干预措施: Placebo (Other)
Part B
Experimental
干预措施: REGN20423 (Drug)
Part B
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 52 weeks
Severity of TEAEs
时间窗: Up to 52 weeks
次要结局
- Percent change from baseline of total TARC(Up to 52 weeks)
- Occurrence of Anti-Drug Antibodies (ADA) to REGN20423(Up to 52 weeks)
- Magnitude of ADA to REGN20423(Up to 52 weeks)
- Percent change in EASI(From baseline up to 52 weeks)
- Absolute values from baseline of total eosinophil counts in blood(Up to 52 weeks)
- Absolute values from baseline of total periostin(Up to 52 weeks)
- Absolute values from baseline of total Thymus and Activation-Regulated Chemokine (TARC)(Up to 52 weeks)
- Percent change from baseline of total IL-13(Up to 52 weeks)
- Concentrations of REGN20423 in serum(Up to 52 weeks)
- Absolute values from baseline of total Interleukin 13 (IL-13)(Up to 52 weeks)
- Absolute values from baseline of total Immunoglobulin E (IgE)(Up to 52 weeks)
- Percent change from baseline of total IgE(Up to 52 weeks)
- Percent change from baseline of total eosinophil counts in blood(Up to 52 weeks)
- Percent change from baseline of total periostin(Up to 52 weeks)
- Absolute change from baseline in Eczema Area and Severity Index (EASI) score(Up to 52 weeks)
- Percent change from baseline in EASI score(Up to 52 weeks)
- Achievement of EASI-50(Up to 52 weeks)
- Achievement of EASI-75(Up to 52 weeks)
- Achievement of EASI-90(Up to 52 weeks)
- Achievement of Investigator's Global Assessment (IGA) 0-1(Up to 52 weeks)
- Achievement of IGA 0-1 with reduction in IGA score by ≥2(Up to 52 weeks)
- Achievement of a reduction in IGA score by ≥2(Up to 52 weeks)
- Absolute change in % Body Surface Area (BSA)(From baseline up to 52 weeks)
- Absolute change in EASI(From baseline up to 52 weeks)
- Percent change in % BSA(From baseline up to 52 weeks)
研究者
研究点 (1)
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