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Monoclonal Antibodies

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

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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to day 85 (sad) or day 113 (md)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 85 (sad) or day 113 (md) for reporting.

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 more
Secondary study objectives
MD: AUCtau
MD:ADA and/or NAb
Patient-reported VOC event rate and VOC day rate
+14 more

Trial 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
4,675 Previous Clinical Trials
28,717,129 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,985 Total Patients Enrolled
~9 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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