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Monoclonal Antibodies
PF-07209326 for Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to day 85 (sad) or day 113 (md)
Summary
This trial tests a new drug called PF-07209326 to see if it is safe and how it behaves in the body. It starts with healthy people and then moves to those with sickle cell disease. The study checks how the drug moves through and affects the body.
Eligible Conditions
- Healthy Subjects
- Sickle Cell Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 up to day 85 (sad) or day 113 (md)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to day 85 (sad) or day 113 (md)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Number of subjects with change from baseline in vital signs
+3 moreSecondary study objectives
MD: AUCtau
MD:ADA and/or NAb
Patient-reported VOC event rate and VOC day rate
+14 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment for SCDExperimental Treatment1 Intervention
Participants will receive a multiple dose of subcutaneous PF-07209326
Group II: Treatment Healthy ParticipantsExperimental Treatment1 Intervention
Participants will receive single ascending doses of subcutaneous (SC) or intravenous PF-07209326
Group III: Placebo Healthy ParticipantsPlacebo Group1 Intervention
Participants will receive matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07209326
2020
Completed Phase 1
~60
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PfizerLead Sponsor
4,658 Previous Clinical Trials
17,877,231 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,407 Total Patients Enrolled
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