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COMPLETED Phase 1

Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease

NCT04255875 · View on ClinicalTrials.gov ↗

Study Summary

This Phase 1 first-in-human, first-in-patient, single ascending dose and multiple dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, and pharmacokinetics of PF-07209326 in healthy participants and participants with sickle cell disease.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL PF-07209326

Study Locations (16)

Florida

  • Golisano Children's Hospital of Southwest Florida — Fort Myers
  • Lee Health - Golisano Children's Hospital of Southwest Florida — Fort Myers
  • Foundation for Sickle Cell Disease Research — Hollywood
  • Foundation for Sickle Cell Disease Research — Hollywood

New York

  • Columbia University Medical Center - Herbert Irving Pavilion — New York
  • CUIMC Research Pharmacy — New York
  • CUMC Research Pharmacy — New York

Texas

  • UT Physicians Comprehensive Sickle Cell Center Houston — Houston
  • Memorial Hermann clinical research unit — Houston
  • UT Physicians Comprehensive Sickle Cell Center Houston — Houston

Illinois

  • University of Illinois at Chicago Clinical Research Center — Chicago
  • University of Illinois at Chicago — Chicago

Connecticut

  • New Haven Clinical Research Unit — New Haven

District of Columbia

  • Howard University College of Medicine — Washington D.C.

Georgia

  • Children's Healthcare of Atlanta - Egleston Hospital-Aflac Cancer and Blood Disorders Center — Atlanta

Minnesota

  • Prism Research LLC dba Nucleus Network — Saint Paul

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2020-02-05
Est. Completion 2023-07-07
Phase Phase 1

Sponsor

Pfizer

769 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04255875

The ClinicalTrials.gov registry entry for NCT04255875 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04255875 reports 16 study locations spanning 8 distinct geographic areas — top geographies include Florida, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04255875 about?

NCT04255875 is a clinical study titled "Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease". This Phase 1 first-in-human, first-in-patient, single ascending dose and multiple dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, and pharmacokinetics of PF-07209326 in healthy participants and participants with sickle cell disease.

What is the current status of trial NCT04255875?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2020-02-05. Estimated completion is 2023-07-07.

What conditions does trial NCT04255875 study?

This clinical trial studies the following conditions: Healthy, Sickle Cell Anemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04255875?

The interventions under investigation include: Placebo (BIOLOGICAL), PF-07209326 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04255875?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04255875 being conducted?

This trial has 16 study locations across Connecticut, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial