A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.
研究概览
简要总结
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IPF, within 5 years prior to Screening,
- •FVC %predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening.
- •DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of screening.
- •Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months
排除标准
- •Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
- •Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio <0.7
- •Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
- •Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
- •Smoking of any kind within 3 months of Screening
研究组 & 干预措施
PLN-74809 Dose Level 1 (60 mg)
PLN-74809 Dose Level 1 (60mg)
干预措施: PLN-74809 (Drug)
PLN-74809 Dose Level 1 (60 mg)
PLN-74809 Dose Level 1 (60mg)
干预措施: Knottin tracer (Radiation)
PLN-74809 Dose Level 2 (80 mg)
PLN-74809 Dose Level 2 (80 mg)
干预措施: PLN-74809 (Drug)
PLN-74809 Dose Level 2 (80 mg)
PLN-74809 Dose Level 2 (80 mg)
干预措施: Knottin tracer (Radiation)
PLN-74809 Dose Level 3 (120 mg)
PLN-74809 Dose Level 3 (120 mg)
干预措施: PLN-74809 (Drug)
PLN-74809 Dose Level 3 (120 mg)
PLN-74809 Dose Level 3 (120 mg)
干预措施: Knottin tracer (Radiation)
PLN-74809 Dose Level 4 (240 mg)
PLN-74809 Dose Level 4 (240 mg)
干预措施: PLN-74809 (Drug)
PLN-74809 Dose Level 4 (240 mg)
PLN-74809 Dose Level 4 (240 mg)
干预措施: Knottin tracer (Radiation)
PLN-74809 Dose Level 4 (320 mg)
PLN-74809 Dose Level 4 (320 mg)
干预措施: PLN-74809 (Drug)
PLN-74809 Dose Level 4 (320 mg)
PLN-74809 Dose Level 4 (320 mg)
干预措施: Knottin tracer (Radiation)
结局指标
主要结局
Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.
时间窗: Following 1 day of dosing
Assessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling.
次要结局
- Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events(From screening to 1 week following the administration of PLN-74809)