NL-OMON51621撤回不适用
A Phase 1, first-in-human, three-part, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAR443726 in healthy adult participants and in adult participants with moderate-to-severe atopic dermatitis. - Safety, tolerability, PK and PD of SAR443726
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Confirmed diagnosis of moderate-to-severe AD for at least 1 year prior to
- •first administration of IMP on Day 1
- •- Quantiferon® - tuberculosis (TB) Gold test must be negative with no prior
- •history of documented tuberculosis irrespective of treatment.
- •- Eczema Area and Severity Index (EASI) score * 12 at screening and * 16 at
- •- Validated IGA score of at least 3 or 4 at Baseline
- •- Atopic dermatitis involvement of *10% of BSA at Baseline
- •- Normal or clinically acceptable vital signs, standard 12-lead ECG parameters,
- •laboratory parameters within the normal range
- •- Body weight between 50.0 and 105.0 kg, inclusive, if male, and between 45.0
- •and 95.0 kg, inclusive, if female, body mass index between 18.0 and 32.0 kg/m2,
- •- Documented history, within 6 months prior to Baseline, of either inadequate
- •response to topical treatments or inadvisability of topical treatments
- •- Participants should make every effort to apply a stable dose of topical bland
- •emollient (simple moisturizer, no additives [eg, urea]) on lesional area at
- •least twice daily for at least 7 consecutive days before Baseline.
- •- Male participants must accept to use, during sexual intercourse, a double
- •contraception method.
- •- A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and one of the following conditions applies: is a woman of
- •nonchildbearing potential (WONCBP) ORIs a woman of childbearing potential
- •(WOCBP) and agrees to use a contraceptive method that is highly effective
排除标准
- •- Presence of dermatologic diseases other than AD that are susceptible to
- •interfere with clinical assessment of AD.
- •- Co-morbid clinically significant disease that might interfere with the
- •evaluation of IMP (eg. but not limited to: uncontrolled diabetes, severe
- •hypertension, severe ischemic heart disease, unstable angina in the last 6
- •months, unstable cardiac arrhythmias, and Class IV heart failure, renal,
- •hepatic or pulmonary disease, neurological condition, cancer any type).
- •Controlled hypertension under stable (unchanged in the last 6 months) treatment
- •with 1 antihypertensive is allowed.
- •- Evidence of acute or chronic infection requiring treatment with
- •antibacterials, antivirals, antifungals, antiparasitics, or antiprotozoals
- •within 4 weeks before Screening visit, significant viral infections within 4
- •weeks before Screening visit that may not have received antiviral treatment
- •(eg, influenza receiving only symptomatic treatment).
- •- Participants with autoimmune disease or using systemic immunosuppressive
- •therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel
- •disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple
- •sclerosis, etc).
- •- Significant blood loss (including blood donation [>450 mL] or plasma donation
- •[>200 mL], within 2 months prior to Screening.
- •- Symptomatic postural hypotension, irrespective of the decrease in blood
- •pressure, or asymptomatic postural hypotension defined as a decrease in
- •systolic blood pressure *30 mmHg within 3 minutes when changing from supine to
- •standing position.
- •- Presence or history of drug hypersensitivity, or relevant allergic disease
- •diagnosed and treated by a physician. Participants with a history of mild
- •seasonal allergies may be included at investigator discretion.
- •- History or presence of drug or alcohol abuse (alcohol consumption more than
- •40 g per day on a regular basis).
- •- Known or suspected history of immunosuppression, including history of
- •invasive opportunistic infections (eg, tuberculosis, histoplasmosis,
- •listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite
- •infection resolution; or unusually frequent, recurrent or prolonged infections,
- •per Investigator's judgment.
- •- Diagnosed active parasitic infection (helminths), suspected or high risk of
- •parasitic infection, unless clinical and (if necessary) laboratory assessments
- •have ruled out active infection before randomization.
- •- Any prior history of malignancy or active malignancy, including
- •lymphoproliferative diseases (except successfully treated carcinoma in-situ of
- •the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin)
- •within 5 years prior to Screening visit.
- •- Treatment with TCS/TCI within 2 weeks prior to Baseline or systemic
- •corticosteroids within 4 weeks prior to Baseline for the management of AD.
- •- Treatment with phototherapy within 2 weeks prior to Baseline for the
- •management of AD.
- •- Exposure to investigational therapies (excluding biologics) within 3 months
- •prior to Baseline.
- •- Any recall vaccination with non-live vaccines including recall vaccination
- •for COVID-19 within the last 4 weeks before first IMP administration (Day 1).
- •- Administration of a live attenuated virus vaccine within 3 months before
- 另有 1 项未显示
研究者
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