NCT05366764已完成1 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SAR443765 in Healthy Adult Participants and of a Single Dose of SAR443765 in Participants With Mild-to-moderate Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events (AEs) /TEAEs
研究概览
简要总结
This is a 3-part, parallel group treatment, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics after sequential single and multiple ascending doses of SAR443765 in healthy adult participants, and after a single dose of SAR443765 in participants with mild-to-moderate asthma.
详细描述
The anticipated study duration per participant is up to 14 weeks
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of asthma for at least 12 months and confirmed at screening based on the Global Initiative for Asthma (GINA) 2020 Guidelines
- •Controlled asthma defined as no more than 1 canister of rescue inhaler per month over the last 3 months prior to baseline
- •Elevated FeNO level defined as ≥25 ppb
- •Participants, using as-needed SABA, ICS-naïve or with existing stable treatment (at least for 3 months prior to screening) with low to medium daily dose ICS (≤500 mcg of fluticasone propionate or comparable ICS daily dosage) potentially in combination with a LABA and/or LAMA as second controller, and/or with stable daily leukotriene receptor antagonist, leukotriene synthesis inhibitor and/or chromones
- •Prebronchodilator forced expiratory volume in 1 second (FEV1) ≥60% of predicted normal
- •Reversibility of at least 12% and 200 mL in FEV1 or forced vital capacity (FVC) after administration of 4 puffs (400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening or documented history of a reversibility test that meets this criteria within 5 years prior to screening or documented positive response to methacholine challenge (a decrease in FEV1 by 20% [PC20] of <8 mg/mL) within 5 years prior to screening visit
- •Body weight between 50.0 and 105.0 kg, inclusive, if male, and between 40.0 and 95.0 kg, inclusive, if female, body mass index between 18.0 and 32.0 kg/m2
- •Male participants are eligible to participate if they use condom during study period
- •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 non-childbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective
- •A WOCBP must have a negative highly sensitive pregnancy test within 36 hours before the first administration of study intervention
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any clinically relevant abnormal findings in medical history, physical examination, vital signs, 12-lead ECG.
- •Chronic lung disease, or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
- •History of life-threatening asthma, asthma exacerbation or use of systemic steroid within 3 months prior to screening visit
- •Worsening of asthma or respiratory infection within the last 6 weeks prior screening visit.
- •Symptomatic postural hypotension,history or presence of drug or alcohol abuse, current smoker or previous smoker with a smoking history >10 pack-years.
- •Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
- •NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
SAR443765
Experimental
Single dose administration of SAR443765
干预措施: SAR443765 (Drug)
SAR443765
Experimental
Single dose administration of SAR443765
干预措施: Salbutamol or levosalbutamol (Drug)
Placebo
Placebo Comparator
Placebo to match SAR443765
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo to match SAR443765
干预措施: Salbutamol or levosalbutamol (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs) /TEAEs
时间窗: From baseline up to Day 71
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
次要结局
- Change in Nitric Oxide (FeNO) level(Day 1 and Day 29)
- Pharmacokinetic (PK) assessment: AUClast(From baseline up to Day 71)
- Presence of Anti-SAR443765 antibodies (ADA)(From baseline up to Day 71)
- Total (free + bound) serum target concentrations of IL-13(From baseline up to Day 71)
- Pharmacokinetic (PK) assessment: Cmax(From baseline up to Day 71)
- Pharmacokinetic (PK) assessment: AUC(From baseline up to Day 71)
- Total (free + bound) serum target concentrations of TSLP(From baseline up to Day 71)
研究者
研究点 (2)
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