NCT05859724终止1 期
A Randomized, Double-blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Exploratory Clinical Activity of NM26-2198 in Healthy Volunteers and in Adult Patients With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 30
- 主要终点
- Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [MAD]
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (SC) administration of NM26-2198 in healthy volunteers and adult patients with moderate to-severe AD to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single (SAD) and multiple doses (MAD) of NM26-2198.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SAD: Non-Asian ethnicity with grandparents and parents of non-Asian descent or Japanese descent having all four Japanese grandparents born in Japan.
- •SAD and MAD in Healthy Volunteers: Male or female aged 18 to 55 years; MAD: Male or female ≥18 years of age.
- •ALL COHORTS: Weight of 45 kg to 100 kg and BMI of 18.0 to 30.0 kg/m
- •SAD and MAD in Healthy Volunteers: Non-childbearing, non-breastfeeding females or males willing to use double barrier contraception or abstention from sex and sperm donation during the study; MAD: Males willing to use double barrier contraception or abstention from sex and sperm donation during the study; non-childbearing females or females of childbearing potential using protocol-defined method contraception, and who is not pregnant, lactating, or breastfeeding.
- •MAD: Diagnosis of chronic AD.
- •MAD: EASI score ≥
- •MAD: vIGA-AD™ score of ≥
- •MAD: Atopic lesions cover ≥10% of body surface area (BSA).
- •MAD: PP-NRS score ≥
- •MAD: Daily use of non-prescription emollient.
- •Note: Other protocol-defined Inclusion criteria apply.
排除标准
- •SAD and MAD in Healthy Volunteers: Any clinically-relevant medical history or lab abnormality, including positive test for SARS-CoV-2, Hepatitis B or C, or HIV; MAD: Clinically-significant, abnormal laboratory findings, or positive test for SARS-CoV-2, Hepatitis B or C, or HIV.
- •ALL COHORTS: Clinically important ECG abnormalities or history/evidence thereof.
- •SAD and MAD in Healthy Volunteers: Use of prescription or non-prescription medications (except occasional use of paracetamol).
- •MAD: Diagnosis of protocol-specified skin diseases other than AD, or history of other significant skin condition that could interfere with study assessments.
- •MAD: History or ongoing allergy/hypersensitivity or history, or history of hypersensitivity to biological drugs.
- •MAD: Recent receipt of immunoglobulin or blood products.
- •MAD: Recent treatment with protocol-specified investigational treatments, or any prior treatment with dupilumab, tralokinumab, lebrikizumab, nemolizumab, or other protocol-specified drugs.
- •MAD: AD with recent ocular involvement requiring chronic ocular corticosteroid treatment.
- •MAD: Chronic pruritis due to conditions other than AD.
- •MAD: Acute AD superinfection, recent superficial skin infection, or other chronic/acute infection requiring protocol-defined treatments.
- •MAD: Recent use of sedating antihistimines, systemic corticosteroids, cytotoxic treatments, other immunosuppressive/immunomodulating agents, and other protocol-specified prohibited medications.
- •MAD: Recent topical corticosteroid or prescription moisturizer use.
- •Note: Other protocol-defined Exclusion criteria apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo (for NM26-2198) for subcutaneous (SC) injection in healthy volunteers (HVs) on Day 1 (SAD Cohorts) and on Days 1, 8, 15, and 22 (MAD Cohorts)
干预措施: Placebo (Other)
NM26-2198
Experimental
NM26-2198 10mg, 50mg, 150mg, 300mg, 400mg, 600mg, and 900mg for SC injection in HVs on Day 1 (SAD Part A); NM26-2198 150mg and 300mg for SC injection in patients with AD on Days 1, 8, 15, and 22 (MAD Part B); NM26-2198 150mg and 300mg for SC injection in HVs on Days 1, 8, 15, and 22 (MAD Part C)
干预措施: NM26-2198 (Biological)
结局指标
主要结局
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [MAD]
时间窗: First dose through end of study (Day 85)
TEAEs defined as AEs and SAEs developing or worsening during treatment period (time from the first dose of study drug up to the end of study visit \[Day 85 in MAD\]), and includes findings from vital signs, electrocardiogram (ECG), clinical laboratory tests, physical examinations, and injection site evaluations.
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [SAD]
时间窗: First dose through end of study (Day 57)
TEAEs defined as AEs and SAEs developing or worsening during treatment period (time from the first dose of study drug up to the end of study visit \[Day 57 in SAD\]), and includes findings from vital signs, electrocardiogram (ECG), clinical laboratory tests, physical examinations, and injection site evaluations.
次要结局
- Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Trough Concentration (Ctrough) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [MAD](Pre-dose on Day 1 through Day 29)
- Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Time of last quantifiable concentration (tlast) [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Time of last quantifiable concentration (tlast) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Terminal elimination half-life (t1/2) [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Total body clearance (CL/F) [SAD](Day 1)
- Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [SAD](Pre-dose on Day 1 through Day 7)
- Pharmacokinetics of NM26-2198: Total body clearance (CL/F) [MAD](Day 1 and Day 22)
- Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [SAD](Pre-dose on Day 1 through Day 57)
- Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Apparent volume of distribution (Vz/F) [MAD](Day 1 and Day 22)
- Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Apparent volume of distribution (Vz/F) [SAD](Day 1)
- Pharmacokinetics of NM26-2198: Accumulation ratio of last dose AUCtau (Racc,AUCtau) [MAD](Day 1 through Day 22)
- Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [MAD](Pre-dose on Day 1 through Day 85)
- Mean ADA titers [SAD](Pre-dose on Day 1 through Day 57)
- Pharmacokinetics of NM26-2198: Terminal elimination half-life (t1/2) [MAD](Pre-dose on Day 1 through Day 85)
- Pharmacokinetics of NM26-2198: Accumulation ratio of last dose Cmax (Racc,cmax) [MAD](Day 1 through Day 22)
- Mean ADA titers [MAD](Pre-dose on Day 1 through Day 85)
研究者
研究点 (30)
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