NCT06920901进行中（未招募）1 期
A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 11
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma.
The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.
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, Care Provider, Investigator)
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
- 否
入选标准
- •Have a diagnosis of mild-to-moderate asthma (Global Initiative for Asthma 2023 criteria) ≥ 1 year prior to Screening
- •Maintain FeNO-high (≥ 25 parts per billion [ppb]) or FeNO-low (< 25 ppb) status from Screening to Day 1 prior to Randomization
- •Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted normal value at Screening
- •Asthma Control Test (ACT) score > 19 at Screening
- •Maintained control on as-needed short-acting beta-agonist (SABA) +/- stable dose inhaled corticosteroids (ICS) or stable dose of ICS/ long-acting beta-agonist (LABA); +/- stable dose leukotriene receptor antagonist (LTRA). ICS dose should be stable for ≥ 12 weeks prior to Day 1, LTRA dose should be stable for ≥ 8 weeks prior to Day 1
- •Women of childbearing potential and male participants to use a highly effective form of contraception
排除标准
- •Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of Screening and/or any asthma exacerbation that resulted in overnight hospitalization within 6 months prior to Screening
- •Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia
- •History of biologics use for treatment or control of asthma
- •Current smokers or participants with a smoking history of ≥ 10 pack years
- •Known history of illicit drug abuse, harmful alcohol use
- •Note: Other protocol defined criteria may apply.
研究组 & 干预措施
APG777
Experimental
Participants will receive protocol specified dose of APG7777
干预措施: APG777 (Drug)
Placebo
Placebo Comparator
Participants will receive matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 52 weeks
Number of Participants with Abnormal Laboratory Findings
时间窗: Up to 52 weeks
Number of Participants with Abnormal Electrocardiograms (ECGs)
时间窗: Up to 52 weeks
Number of Participants with Abnormal Physical Examination Findings
时间窗: Up to 52 weeks
Number of Participants with Abnormal Vital Signs
时间窗: Up to 52 weeks
次要结局
- Time to reach Cmax (tmax)(Up to 48 weeks)
- Terminal elimination rate constant (λz)(Up to 48 weeks)
- Terminal Elimination half-life (t1/2)(Up to 48 weeks)
- Area Under the Serum Concentration-time curve (AUC) from Time 0 to the Last Quantifiable Time Point (AUC0-last)(Up to 48 weeks)
- AUC From Time 0 Extrapolated to Infinity (AUC0-inf)(Up to 48 weeks)
- Apparent Clearance of APG777 (CL/F)(Up to 48 weeks)
- Apparent Volume of Distribution (Vz/F)(Up to 48 weeks)
- Number of Participants with Anti-Drug-Antibodies (ADAs)(Up to 48 weeks)
- Cmax in Participants With and without ADAs(Up to 48 weeks)
- AUClast Participants With and without ADAs(Up to 48 weeks)
- AUCInf Participants With and without ADAs(Up to 48 weeks)
- Maximum concentration (Cmax) of APG777(Up to 48 weeks)
研究者
研究点 (11)
Loading locations...
相似试验
已完成
1 期
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CC-90006 in Subjects With Mild to Moderate Plaque-type PsoriasisPsoriasisNCT03337022Celgene34
已完成
1 期
Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus VaccineNorovirus InfectionsNCT04854746Vaxart66
终止
1 期
A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive DeclineCognitive DeclineNCT05199142Syndesi Therapeutics5
已完成
1 期
Allergic Disease Onset Prevention StudyAtopic DermatitisType 1 HypersensitivityNCT05003804Siolta Therapeutics, Inc.283
已完成
1 期
A Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA-720 Adjuvant in 18-45 Year Old Healthy VolunteersYellow Fever ImmunisationYellow FeverNCT02743455National Institute of Allergy and Infectious Diseases (NIAID)92