Retrospective, Multi-Center Observational Study Evaluating the Kinetic Safety and Tolerability of an Intravenous Micellar Excipient Platform in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 625
- 试验地点
- 1
研究概览
简要总结
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform. Researchers will abstract medical records of individuals who previously received this infusion in a clinical setting. The main questions the study aims to answer are: What adverse events (AEs) did participants experience during or after the infusion? Did participants discontinue their infusion regimen early due to adverse events? Researchers will abstract charts from clinical exposures occurring between June 1, 2025, and April 15, 2026. Participants do not undergo any new interventions or clinic visits.
详细描述
Detailed Description: Protocol PICO-RWE-001 I. SCIENTIFIC RATIONALE AND PLATFORM ARCHITECTURE Protocol PICO-RWE-001 is a retrospective, multi-center observational clinical investigation designed to establish the systemic safety and tolerability profile of a proprietary sub-nanometer micellar delivery platform. The platform utilizes a specialized 850-picometer hydrophilic emulsion, engineered to encapsulate lipophilic organic compounds (PIV-850 and legacy heterogeneous payloads) for intravenous administration.
In biopharmaceutical development, particle size is a primary determinant of safety and biological fate. By operating at a sub-1nm scale, the Pico IV platform seeks to bypass the "Delivery Wall"-the biological and mechanical barriers that typically lead to embolic risk or infusion-related reactions (CARPA) when oil-in-water emulsions are administered systemically. This study aims to provide the irrefutable human safety data required to support a 505(b)(2) Investigational New Drug (IND) application and a subsequent petition for Phase 1 safety waivers.
II. METHODOLOGICAL ARCHITECTURE AND BIAS MITIGATION To ensure the highest tier of evidence for FDA CDER review and rigorous biostatistical evaluation, the study employs a rigorous Consecutive Selection Algorithm.
Sampling Integrity: Each of the maximum 25 activated clinical sites is mandated to abstract a minimum of 15 and a maximum of 25 unique patient records. Abstractors must identify every patient exposure administered within the eligibility window (June 1, 2025 - April 15, 2026) and work chronologically backward from the end date. This 100% consecutive sampling protocol is mathematically designed to eliminate selection bias.
CMC Standardization: Data abstraction is strictly limited to patient exposures utilizing single-use sterile vials. This ensures the safety signals collected perfectly mirror the Sponsor's intended commercial Chemistry, Manufacturing, and Controls (CMC) sterile fill-finish protocols, neutralizing multi-use cross-contamination variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Participant must have received at least one intravenous (IV) investigational exposure of the PICO IV 850-picometer micellar platform (evaluating either a legacy heterogeneous payload or the PIV-850 synthetic-equivalent dual-NCE matrix) between June 1, 2025, and April 15,
- •The investigational product administered must have been drawn exclusively from a Single-Use Sterile Vial.
- •The participant record must have been identified via a 100% consecutive sampling algorithm (15 to 25 patients per site) at the clinical site to eliminate selection bias.
- •Electronic Medical Record (EMR) or clinic infusion logs must contain complete data regarding dosing, administration route (IV Push vs. IV Drip), and post-infusion safety observations.
排除标准
- •Participants whose exposures were drawn from legacy multi-use vials.
- •Participants with exposures occurring outside the specific date window of June 1, 2025 - April 15,
- •Participants with incomplete clinical records where Infusion-Emergent Adverse Events (IEAEs) or safety outcomes were not documented.
- •Participants whose records were not identified chronologically backward from April 15, 2026.