[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639776":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":58,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":87,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"PICO IV, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Legacy Payload (Micellar Vehicle)",null,"Participants who received intravenous infusions of the 850-picometer Polysorbate 80 micellar excipient vehicle carrying a legacy heterogeneous payload in a clinical setting between June 1, 2025, and April 15, 2026.",[13],"Drug: Legacy Heterogeneous Payload (Micellar Vehicle)",{"label":15,"type":10,"description":16,"interventionNames":17},"PIV-850 Dual-NCE (Micellar Vehicle)","Participants who received intravenous infusions of the 850-picometer Polysorbate 80 micellar excipient vehicle carrying the highly purified PIV-850 synthetic-equivalent dual-API NCE matrix in a clinical setting between June 1, 2025, and April 15, 2026.",[18],"Drug: PIV-850 (850-picometer Dual-NCE Acidic Matrix)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","PIV-850 (850-picometer Dual-NCE Acidic Matrix)","An investigational, highly purified synthetic-equivalent New Chemical Entity (NCE) formulation comprising an acidic small-molecule complex, encapsulated in a proprietary 850-picometer hydrophilic micelle delivery system. Trace neutral byproducts generated during the thermal\u002Fultrasonic manufacturing process are thermodynamically arrested within the micelle and classified strictly as inactive specified degradants (ICH Q3B limits). The formulation is engineered for intravenous (IV) administration via push or drip. This study observes the systemic safety, kinetic tolerability, and absence of Complement Activation-Related Pseudoallergy (CARPA) for this specific NCE profile in routine clinical practice.",[15],[26],"CORE-A",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Legacy Heterogeneous Payload (Micellar Vehicle)","A legacy iteration of the 850-picometer micellar delivery platform evaluating early kinetic safety thresholds. The Polysorbate 80 vehicle payload consisted of a broad heterogeneous precursor mixture. This formulation was administered intravenously (IV) via push or drip in clinical settings. Retrospective data abstracted from this cohort is utilized strictly to isolate the kinetic safety margin, thermodynamic stability, and tolerability of the delivery vehicle, entirely independent of the active payload.",[9],[32],{"name":33,"affiliation":34,"role":35},"Aimee Aquitania, Nurse Practitioner","Wellness Mobile Nursing SoCal Corporation","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Joseph Young, Bachelor of Arts","CONTACT","855-900-0020","jyoung@picoiv.com",{"name":33,"role":39,"phone":40,"phoneExt":10,"email":43},"clinicals@picoiv.com",[45],{"facility":46,"status":10,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":10},"PICO IV Central Data Coordinating Center","Sacramento","California","95811","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-121.4944,38.58157,{"lat":56,"lon":55},{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100639776","retrospective-kinetic-safety-evaluation-of-an-intravenous-micellar-excipient-platform-100639776",false,"NCT07609069","Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform","Retrospective, Multi-Center Observational Study Evaluating the Kinetic Safety and Tolerability of an Intravenous Micellar Excipient Platform in Clinical Practice","Inclusion Criteria:\n\n* 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, 2026.\n* The investigational product administered must have been drawn exclusively from a Single-Use Sterile Vial.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Participants whose exposures were drawn from legacy multi-use vials.\n* Participants with exposures occurring outside the specific date window of June 1, 2025 - April 15, 2026.\n* Participants with incomplete clinical records where Infusion-Emergent Adverse Events (IEAEs) or safety outcomes were not documented.\n* Participants whose records were not identified chronologically backward from April 15, 2026.","ALL","18 Years",{"count":70,"type":71},625,"ESTIMATED","OBSERVATIONAL","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.",[75,76],"Drug Related Side Effects and Adverse Reactions","Infusion Reactions",[78,79,80,81,82,83,84,85,86],"Sub-nanometer delivery system","Micellar nanotechnology","Real-World Evidence (RWE)","505(b)(2) Regulatory Pathway","Antimicrobial Resistance (AMR)","Biofilm Disruption","Excipient Safety","Polysorbate 80","Immunomodulation","NOT_YET_RECRUITING","2026-05-26",{"date":90,"type":91},"2026-05-29","ACTUAL",{"date":93,"type":71},"2026-05-21",{"date":95,"type":71},"2026-07-30",{"name":5,"class":6},1]