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NCT04255875 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease
A Phase 1 study of Healthy and Sickle Cell Anemia, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 16
- Study locations
NCT04255875: Completed Phase 1 study of Healthy and Sickle Cell Anemia, sponsored by Pfizer.
NCT04255875 is a Phase 1 study of Healthy and Sickle Cell Anemia that has completed, run by Pfizer. The registered enrollment target is 52 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 16 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04255875, a Phase 1 study of Healthy and Sickle Cell Anemia, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 16
- Study locations
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.
Primary Outcome
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2023-07-07 |
| Phase | Phase 1 |
What the finished NCT04255875 record still lists
NCT04255875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).
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.
NCT04255875 lists 16 locations in 8 states (Florida, New York, Texas).
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.
What interventions are being tested in trial NCT04255875?
The interventions under investigation include: Placebo (BIOLOGICAL), PF-07209326 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04255875?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04255875's enrollment target sits among peer trials
52 441st of 1090 higher than 646 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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