A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

Официальное название

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)

Обзор

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)

Подробное описание

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

Вмешательства

• Препарат ZL-1503
  Healthy volunteers will receive ZL-1503.
• Препарат Placebo
  Healthy volunteers will receive placebo.
• Препарат ZL-1503
  Participants with moderate to severe atopic dermatitis will receive ZL-1503.
• Препарат Placebo
  Participants with moderate to severe atopic dermatitis will receive placebo.

Первичные конечные точки

• Number of participants with adverse events (AEs) [Срок оценки: Up to 48 weeks after last intervention]
• Number of participants with serious adverse events (SAEs) [Срок оценки: Up to 48 weeks after last intervention]
• Number of participants with clinical laboratory abnormalities [Срок оценки: Up to 48 weeks after last intervention]
• Number of participants with vital sign abnormalities [Срок оценки: Up to 48 weeks after last intervention]
• Number of participants with electrocardiogram (ECG) abnormalities [Срок оценки: Up to 48 weeks after last intervention]

Критерии участия

Критерии включения

• Part A:

• 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.
• Part B:

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Новая Зеландия · 6 центров

• Aotearoa Clinical Trials — Auckland
• Momentum Auckland — Takapuna
• Momentum Hamilton — Hamilton
• Momentum Palmerston North — Palmerston North
• Momentum Hutt Valley — Upper Hutt
• Momentum Kapiti — Waikanae

Китай · 4 центра

• Peking University Third Hospital — Пекин
• Shandong Provincial Dermatology Hospital — Цзинань
• Shanghai Skin Disease Hospital — Шанхай
• Hangzhou First People's Hospital — Ханчжоу

Австралия · 2 центра

• Veracity Clinical Research — Woolloongabba
• Skin Health Institute — Carlton

Идентификаторы

NCT: NCT07235384 · ZL-1503-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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