Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Di… (NCT04255875) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease
United States52 participantsStarted 2020-02-05
Plain-language 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.
Who can participate
Age range
16 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, immunocompromised (or known disorder of the immune system), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
. 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.
. History of active or latent tuberculosis (TB) regardless of treatment or positive QuantiFeron TB test.
. Participants with any of the following acute or chronic infections or infection history:
. Participants with a history of allergic or anaphylactic reaction to therapeutic or diagnostic protein.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Timeframe: Day 1 up to Day 85 (SAD) or Day 113 (MD)
2
Percentage of subjects with laboratory abnormalities
Timeframe: Day 1 up to Day 85 (SAD) or Day 113 (MD)
3
Number of subjects with change from baseline in vital signs
Timeframe: Day 1 up to Day 85 (SAD) or Day 85 (MD)
4
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Timeframe: Day 1 up to Day 85 (SAD) or Day 85 (MD)
5
Percentage of subjects with injection site reactions
Timeframe: Day 1 up to Day 11 post (SAD) Day 1 up to Day 85 (MD)
6
Percentage of subjects with infusion site reactions
. 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.
. Participants between the ages of 16 and 70 years old with a confirmed diagnosis of stable sickle cell disease (HbSS or HBS β0 thalassemia).
. Medical history of ≥2 and ≤ 10 medical utilization VOCs in 12 months prior to screening.