Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease
NCT ID: NCT04255875
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2020-02-05
2023-07-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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Treatment Healthy Participants
Participants will receive single ascending doses of subcutaneous (SC) or intravenous PF-07209326
PF-07209326
Participants will receive SC or IV single ascending doses
Placebo Healthy Participants
Participants will receive matching placebo
Placebo
Participants will receive matching placebo
Treatment for SCD
Participants will receive a multiple dose of subcutaneous PF-07209326
PF-07209326
SCD participants will receive a multiple dose of subcutaneous PF-07209326
Interventions
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Placebo
Participants will receive matching placebo
PF-07209326
Participants will receive SC or IV single ascending doses
PF-07209326
SCD participants will receive a multiple dose of subcutaneous PF-07209326
Eligibility Criteria
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Inclusion Criteria
1. Participants between the ages of 16 and 70 years old with a confirmed diagnosis of stable sickle cell disease (HbSS or HBS β0 thalassemia).
2. Medical history of ≥2 and ≤ 10 medical utilization VOCs in 12 months prior to screening.
3. ≥75% of daily ePRO diary completion, over a minimum of 14 days during the screening period.
4. Fully vaccinated for COVID-19 in accordance with the Center for Disease Control guidance prior to Screening or must be negative for SARS-CoV-2 by polymerase chain reaction (PCR) within 72 hours of the Day 1 visit.
5. Body Mass Index (BMI) ≤34.9 kg/m2 and weight ≥50 kg.
Exclusion Criteria
2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
3. History of active or latent tuberculosis (TB) regardless of treatment or positive QuantiFeron TB test.
4. Participants with any of the following acute or chronic infections or infection history:
* Any infection requiring treatment within 2 weeks prior to the screening visit.
* Any infection requiring hospitalization, parenteral antimicrobial therapy within 30 days of the first dose of investigational product.
* Any infection judged to be an opportunistic infection, within the past 6 months of the first dose of the investigational product.
* Known active or history of frequent bacterial, viral, fungal, mycobacterial or other infections as determined by the PI.
* Participants with a fever within the last 7 days prior to dosing.
5. Participants with a history of allergic or anaphylactic reaction to therapeutic or diagnostic protein.
6. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
1. Evidence of ongoing uncontrolled clinically significant co-morbidity (e.g. intercurrent events that result in signs symptoms that have an adverse impact on the respective individual's usual function) hematological (non-SCD), renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including stroke within 2 years prior to screening), hepatic, psychiatric or neurological.
2. Evidence or history of cardiac disease includes myocardial infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, and ventricular tachycardia), left ventricular failure, unstable angina, and coronary artery bypass grafting.
3. History of cancer (other than cutaneous basal cell or carcinoma in-situ) in the previous 5 years.
4. Active infection with Hepatitis B or C or HIV. Individuals seropositive for infection with Hepatitis C must be negative for viral RNA by PCR on at least 2 determinations.
5. History of active or latent tuberculosis (TB) regardless of treatment or positive QuantiFeron TB test.
6. Major surgery \<3 months prior to baseline or planned significant medical procedures during the study.
7. Participants with any of the following acute or chronic infections or infection history:
* Any infection requiring systemic treatment within 2 weeks prior to the screening visit.
* Any infection requiring hospitalization, parenteral antimicrobial therapy within 30 days of the first dose of investigational product.
* Any infection judged to be an opportunistic infection, within the past 6 months of the first dose of the investigational product.
* Known active or history of frequent viral, fungal or other infections as determined by the Investigator.
* Participants with a fever within the last 7 days prior to dosing.
8. Evidence or history of clinically significant orthostatic blood pressure changes.
9. Other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
10. Participants with a history of allergic or anaphylactic reaction to therapeutic or diagnostic protein.
11. Administration of voxelotor within 4 weeks prior to screening or planned use during the study.
12. Administration of crizanlizumab within 12 weeks prior to screening or planned use during the study.
13. Planned transfusion during the study.
16 Years
70 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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New Haven Clinical Research Unit
New Haven, Connecticut, United States
Howard University College of Medicine
Washington D.C., District of Columbia, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Lee Health - Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States
Children's Healthcare of Atlanta - Egleston Hospital-Aflac Cancer and Blood Disorders Center
Atlanta, Georgia, United States
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States
CUIMC Research Pharmacy
New York, New York, United States
CUMC Research Pharmacy
New York, New York, United States
UT Physicians Comprehensive Sickle Cell Center Houston
Houston, Texas, United States
Memorial Hermann clinical research unit
Houston, Texas, United States
UT Physicians Comprehensive Sickle Cell Center Houston
Houston, Texas, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4071001
Identifier Type: -
Identifier Source: org_study_id