NCT06922448已完成2 期
A Phase 2a Randomized Double-blinded Placebo Controlled Study to Evaluate the Safety, Tolerability, PK, PD, and Preliminary Clinical Activity of BLU-808, a Wild-type KIT Inhibitor, in Participants With Ragweed (Ambrosia Artemisiifolia)-Induced Allergic Rhinoconjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of BLU-808 in participants with ragweed (Ambrosia artemisiifolia)-induced allergic rhinoconjunctivitis (ARC). Participants will undergo eligibility assessments that include exposure to ragweed pollen in an allergen exposure chamber (AEC).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, 18 years of age or older, willing to provide written informed consent, and willing to comply with all study requirements.
- •History (>2 years) of ragweed-induced ARC.
- •A positive ragweed skin prick test (mean diameter of ≥ 5 mm) in the last 6 months.
- •Must meet clinically relevant nasal and ocular symptoms as defined by the protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria are met:
- •Receiving medications (oral, nasal, topical, ocular, or injectable) to treat their ragweed or other allergy symptoms and/or receiving any medications that impact participants' safety or interfere with study assessments or interpretation of study results.
- •Have active rhinitis, sinusitis, and/or other severe allergies not associated with the ragweed pollen that may interfere with study symptom assessments.
- •Any prior or ongoing clinically significant illness, medical or psychiatric condition, surgical history, or physical finding that may interfere with the assessment or interpretation of study results.
- •Clinically significant moderate to severe, uncontrolled cardiovascular, renal or hepatic disease.
- •Significant bleeding risk or coagulation disorders.
- •Any form of smoking, vaping or history of alcohol and drug abuse.
- •Any malignancy within the past 5 years prior to Screening/AEC 1, except for basal cell or squamous cell carcinomas of the skin or carcinoma in situ.
- •Inadequately controlled asthma that could affect the safety of the participant or interfere with the assessment or interpretation of study results.
- •Known active/latent infection (viral, bacterial, fungal, helminth, or mycobacterial) such as tuberculosis, hepatitis B, hepatitis C, AIDS-related illness, or COVID-19 infection.
- •History of sinonasal conditions that may confound the assessment or interpretation of study results.
研究组 & 干预措施
BLU-808 Dose 1
Experimental
BLU-808 will be administered orally for 28 days.
干预措施: BLU-808 (Drug)
BLU-808 Dose 2
Experimental
BLU-808 will be administered orally for 28 days.
干预措施: BLU-808 (Drug)
Placebo
Placebo Comparator
Placebo will be administered orally for 28 days.
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: Day 1 through Day 56
次要结局
- Minimum Plasma Concentration (Cmin) of BLU-808(Day 1 to Day 28)
- Change in Baseline-adjusted AUC of the TNSS(Baseline, Day 14, Day 28)
- Area Under the Curve (AUC) of BLU-808(Day 1 to Day 28)
- Maximum Plasma Concentration (Cmax) of BLU-808(Day 1 to Day 28)
- Apparent Clearance (CL/F) of BLU-808(Day 1 to Day 28)
- Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808(Day 1 to Day 28)
- Terminal Half-life (t½) of BLU-808(Day 1 to Day 28)
- Change in Baseline-adjusted Mean Total Nasal Symptom Score (TNSS)(Baseline, Day 14, Day 28)
研究者
研究点 (1)
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