A Phase 1/1b Randomized, Double Blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis (AD)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 13
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
This is a phase 1/1b randomized, double blind, placebo-controlled, single dose escalation (SAD) and multiple dose escalation (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)
详细描述
The study consists of two parts:
- Part A: single ascending dose in healthy volunteers
- Part B: multiple ascending doses in adult participants with moderate to severe AD
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
- Triple (Participant, 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
- •Healthy male and female volunteers, 18-65 years of age
- •Body mass index (BMI) between ≥ 18.5 and < 32.5 kg/m2
- •Negative pregnancy tests for women of childbearing potential.
- •18-65 years of age;
- •BMI between ≥18.5 and <40.0 kg/m2
- •Have a diagnosis of AD at least 12 months prior to Day 1;
- •Moderate-to-severe AD at Screening and Baseline visit, defined as:
- •Eczema Area and Severity Index (EASI) score ≥ 16;
- •Affected Body Surface Area (BSA)≥ 10%;
- •vIGA-AD™ score ≥ 3
- •History of an inadequate response to treatment with topical medications
- •Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
- •Negative pregnancy tests for women of childbearing potential.
排除标准
- •Part A and B:
- •Significant health issues, such as positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), active tuberculosis, immunodeficiencies or autoimmune diseases.
- •History of major metabolic, liver, kidney, hematologic or other significant disorders.
- •Abnormal Electrocardiogram (ECG) findings
- •Clinically relevant abnormal lab results, including low blood counts, or abnormal liver and kidney function.
- •History of drug abuse or addiction within 6 months prior to screening
- •Current smoker or use of any nicotine or tobacco containing products within the last 6 months prior to dosing.
- •Donated >500mL blood within 2 months of dosing.
- •For Part B only:
- •Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments.
- •Uncontrolled chronic disease that might require bursts of oral corticosteroids.
- •Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
研究组 & 干预措施
ZL-1503: Participants will receive multiple ascending doses of ZL-1503
Part B: Multiple Ascending Dose (MAD)
干预措施: ZL-1503 (Drug)
ZL-1503: Participants will receive single ascending doses of ZL-1503
Part A: Single Ascending Dose (SAD)
干预措施: ZL-1503 (Drug)
ZL-1503: Participants will receive single ascending doses of ZL-1503
Part A: Single Ascending Dose (SAD)
干预措施: Placebo (Drug)
ZL-1503: Participants will receive multiple ascending doses of ZL-1503
Part B: Multiple Ascending Dose (MAD)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 48 weeks after last intervention
Number of participants with serious adverse events (SAEs)
时间窗: Up to 48 weeks after last intervention
Number of participants with clinical laboratory abnormalities
时间窗: Up to 48 weeks after last intervention
Number of participants with vital sign abnormalities
时间窗: Up to 48 weeks after last intervention
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to 48 weeks after last intervention
次要结局
未报告次要终点