Drug Related Side Effects and Adverse ReactionsNCT07609069
Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
An observational study of Drug Related Side Effects and Adverse Reactions and Infusion Reactions, run by PICO IV, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Related Side Effects and Adverse Reactions, Infusion Reactions
- What is being tested?
- PIV-850 (850-picometer Dual-NCE Acidic Matrix)
- Type of treatment
- Injection or infusion
- How many people
- 625 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2026to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of a retrospective cohort of subjects who received (IV) infusions of the Sponsor's proprietary sub-nanometer micellar delivery platform (evaluating a legacy heterogeneous payload and the highly purified PIV-850 synthetic-equivalent dual-NCE matrix) within private medical clinics, specialty infusion centers, and outpatient practice settings across the United States. The sample is drawn from a diverse clinical population evaluated between June 1, 2025, and April 15, 2026. To ensure high-fidelity safety data and eliminate selection bias, the population is derived via a mandatory 100% consecutive sampling algorithm at each activated site. This cohort represents subjects receiving investigational micellar infusions for a range of legacy clinical observations in routine medical practice, utilizing exclusively single-use sterile vials to ensure alignment with pharmaceutical-grade Chemistry, Manufacturing, and Controls (CMC) sterile fill-finish standards.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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, 2026.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
PICO IV Central Data Coordinating Center
Sacramento, California, 95811
About this study
Official title: Retrospective, Multi-Center Observational Study Evaluating the Kinetic Safety and Tolerability of an Intravenous Micellar Excipient Platform in Clinical Practice
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.
Read the detailed description
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.
III. CLINICAL STRATIFICATION AND KINETIC SAFETY
The study abstracts granular data to assess the "Excipient Kinetic Safety Margin." The data is stratified to evaluate the following variables:
Formulation Evolution: Safety profiles are compared between the legacy heterogeneous formulations and the purified PIV-850 isolate to identify any variance in tolerability linked to trace neutral byproducts or minor organic components.
Administration Velocity: The study analyzes safety outcomes between "IV Push" and "IV Drip" protocols. This allows the Sponsor to determine the relationship between systemic infusion rates and the incidence of transient infusion-related reactions.
Dose-Escalation Safety: Retrospective dosing data capturing extreme supratherapeutic exposures to provide a clinical view of the dose-response safety curve in a diverse, real-world population.
IV. SAFETY MONITORING PARAMETERS
The abstraction process focuses on identifying both systemic and localized adverse events (AEs). Specific clinical markers include:
Complement Activation-Related Pseudoallergy (CARPA): Monitoring for flushing, dyspnea, and tachycardia to validate the immunological "stealth" of the 850-picometer micelle.
Vehicle Toxicity: Evaluating renal and hepatic markers (where available in charts) and general systemic tolerability to confirm the safety of the Polysorbate 80-based vehicle load.
Longitudinal Tolerability: Assessing the rate of infusion regimen completion versus early discontinuation due to intolerance.
- REGULATORY AND STRATEGIC RATIONALE By formalizing up to 625 human exposures into a structured, de-identified database, PICO IV is leveraging Real-World Evidence (RWE) to establish an Excipient Kinetic Safety Bridge. This study functions as the definitive safety foundation for a 505(b)(2) IND application, demonstrating that the sub-nanometer architecture is both safe and stable in a broad human population.
- Being tested
- PIV-850 (850-picometer Dual-NCE Acidic Matrix), Legacy Heterogeneous Payload (Micellar Vehicle)
- Keywords
- 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
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIV-850 (850-picometer Dual-NCE Acidic Matrix)Drug
Also called CORE-A
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/ultrasonic 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.
Legacy Heterogeneous Payload (Micellar Vehicle)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Legacy Payload (Micellar Vehicle) | 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. Receives: Drug: Legacy Heterogeneous Payload (Micellar Vehicle) | |
| 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. Receives: Drug: PIV-850 (850-picometer Dual-NCE Acidic Matrix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Infusion-Emergent Adverse Events (IEAEs)
Percentage of participants experiencing adverse events as documented in clinical charts. This includes specific monitoring for: 1) Infusion-Related Reactions: Complement Activation-Related Pseudoallergy (CARPA) symptoms such as facial flushing, dyspnea, tachycardia, or back/flank pain. 2) Vehicle Toxicity: Clinical signs of systemic intolerance to the Polysorbate 80-based micellar vehicle. Severity Grading: Events are systematically mapped and graded per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Grades 1-5).
Measured: From the initiation of the first intravenous infusion through 24 hours post-infusion.
Secondary outcomes (2)
Rate of Early Infusion Discontinuation Due to Intolerance
The percentage of participants who discontinued their intended course of IV infusions specifically due to an adverse event or intolerance to the micellar formulation.
Measured: Duration of individual clinical exposure, up to 46 weeks.
Maximum Observed Dose Tolerability
Documentation of the highest dose tier (measured in total milligrams of active small-molecule payload) administered to participants without the occurrence of a severe adverse event. Retrospective abstraction will capture extreme supratherapeutic exposures (including multi-vial administrations exceeding the standard single-vial volume) to establish the maximum kinetic safety ceiling of the micellar delivery vehicle, providing a definitive safety margin for future prospective clinical targets.
Measured: Duration of individual clinical exposure, up to 46 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start21 May 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Related Side Effects and Adverse ReactionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PICO IV, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aimee Aquitania, Nurse Practitioner, Principal investigator, Wellness Mobile Nursing SoCal Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609069
- Sponsor's protocol ID
- PICO-RWE-001
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Multi-Center Observational Study Evaluating the Kinetic Safety and Tolerability of an Intravenous Micellar Excipient Platform in Clinical Practice
- ClinicalTrials.gov ID
- NCT07609069
- Acronym / sponsor ID
- PICO-RWE-001
- Keywords
- Sub-nanometer delivery system, Micellar nanotechnology, Real-World Evidence (RWE), 505(b)(2) Regulatory Pathway, Antimicrobial Resistance (AMR), Biofilm Disruption, Excipient Safety, Polysorbate 80
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- PICO IV, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
III. CLINICAL STRATIFICATION AND KINETIC SAFETY
The study abstracts granular data to assess the "Excipient Kinetic Safety Margin." The data is stratified to evaluate the following variables:
Formulation Evolution: Safety profiles are compared between the legacy heterogeneous formulations and the purified PIV-850 isolate to identify any variance in tolerability linked to trace neutral byproducts or minor organic components.
Administration Velocity: The study analyzes safety outcomes between "IV Push" and "IV Drip" protocols. This allows the Sponsor to determine the relationship between systemic infusion rates and the incidence of transient infusion-related reactions.
Dose-Escalation Safety: Retrospective dosing data capturing extreme supratherapeutic exposures to provide a clinical view of the dose-response safety curve in a diverse, real-world population.
IV. SAFETY MONITORING PARAMETERS
The abstraction process focuses on identifying both systemic and localized adverse events (AEs). Specific clinical markers include:
Complement Activation-Related Pseudoallergy (CARPA): Monitoring for flushing, dyspnea, and tachycardia to validate the immunological "stealth" of the 850-picometer micelle.
Vehicle Toxicity: Evaluating renal and hepatic markers (where available in charts) and general systemic tolerability to confirm the safety of the Polysorbate 80-based vehicle load.
Longitudinal Tolerability: Assessing the rate of infusion regimen completion versus early discontinuation due to intolerance.
- REGULATORY AND STRATEGIC RATIONALE By formalizing up to 625 human exposures into a structured, de-identified database, PICO IV is leveraging Real-World Evidence (RWE) to establish an Excipient Kinetic Safety Bridge. This study functions as the definitive safety foundation for a 505(b)(2) IND application, demonstrating that the sub-nanometer architecture is both safe and stable in a broad human population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Legacy Payload (Micellar Vehicle) | – | Drug: Legacy Heterogeneous Payload (Micellar Vehicle)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. |
| PIV-850 Dual-NCE (Micellar Vehicle) | – | Drug: PIV-850 (850-picometer Dual-NCE Acidic Matrix)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of a retrospective cohort of subjects who received (IV) infusions of the Sponsor's proprietary sub-nanometer micellar delivery platform (evaluating a legacy heterogeneous payload and the highly purified PIV-850 synthetic-equivalent dual-NCE matrix) within private medical clinics, specialty infusion centers, and outpatient practice settings across the United States. The sample is drawn from a diverse clinical population evaluated between June 1, 2025, and April 15, 2026. To ensure high-fidelity safety data and eliminate selection bias, the population is derived via a mandatory 100% consecutive sampling algorithm at each activated site. This cohort represents subjects receiving investigational micellar infusions for a range of legacy clinical observations in routine medical practice, utilizing exclusively single-use sterile vials to ensure alignment with pharmaceutical-grade Chemistry, Manufacturing, and Controls (CMC) sterile fill-finish standards.
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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, 2026.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIV-850 (850-picometer Dual-NCE Acidic Matrix)Also: CORE-AAn 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/ultrasonic 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. | Drug | PIV-850 Dual-NCE (Micellar Vehicle) |
| 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. | Drug | Legacy Payload (Micellar Vehicle) |
Primary outcome
Incidence and Severity of Infusion-Emergent Adverse Events (IEAEs)
Time frame: From the initiation of the first intravenous infusion through 24 hours post-infusion.
Percentage of participants experiencing adverse events as documented in clinical charts. This includes specific monitoring for: 1) Infusion-Related Reactions: Complement Activation-Related Pseudoallergy (CARPA) symptoms such as facial flushing, dyspnea, tachycardia, or back/flank pain. 2) Vehicle Toxicity: Clinical signs of systemic intolerance to the Polysorbate 80-based micellar vehicle. Severity Grading: Events are systematically mapped and graded per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Grades 1-5).
2 secondary outcomes
Rate of Early Infusion Discontinuation Due to Intolerance
Time frame: Duration of individual clinical exposure, up to 46 weeks.
Maximum Observed Dose Tolerability
Time frame: Duration of individual clinical exposure, up to 46 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aimee Aquitania, Nurse Practitioner principal investigator
Wellness Mobile Nursing SoCal Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Related Side Effects and Adverse Reactions and Infusion Reactions, run by PICO IV, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Young, Bachelor of Arts (855-900-0020, jyoung@picoiv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Infusion-Emergent Adverse Events (IEAEs) (time frame: From the initiation of the first intravenous infusion through 24 hours post-infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.