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Monoclonal Antibodies

PF-07209326 for Sickle Cell Anemia

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)
Awards & highlights

Study Summary

This trial will test a new drug to see if it is safe and effective in people with sickle cell disease.

Eligible Conditions
  • Sickle Cell Anemia
  • Healthy Subjects

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
4,575 Previous Clinical Trials
10,923,049 Total Patients Enrolled
2 Trials studying Sickle Cell Anemia
62 Patients Enrolled for Sickle Cell Anemia
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,482 Previous Clinical Trials
8,099,311 Total Patients Enrolled
2 Trials studying Sickle Cell Anemia
179 Patients Enrolled for Sickle Cell Anemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could PF-07209326 prove injurious to patients?

"The safety of PF-07209326 is assessed as a 1, since this Phase 1 trial has limited data supporting its efficacy and security."

Answered by AI

Is the cutoff age for this trial less than 70 years old?

"The requirements for entrance into this clinical trial specify that the age of participants must fall between 18 and 55 years old."

Answered by AI

How many healthcare centers are participating in the current experiment?

"The University of Illinois at Chicago Clinical Research Center in New york, Columbia University Medical Center - Herbert Irving Pavilion in Atlanta, and Children's Healthcare of Atlanta - Egleston Hospital-Aflac Cancer and Blood Disorders Centre in Washington are among the 12 recruiting sites for this clinical trial. Several additional medical centres are also participating."

Answered by AI

Who is eligible to participate in this research study?

"In order to be considered for this clinical trial, applicants must display anemic tendencies, a diagnosis of sickle cell disease and age between 18-55. The total number of participants being sought is 54 individuals."

Answered by AI

Are there any vacancies remaining in this medical trial?

"Indeed, the trial is actively recruiting. It was first advertised on February 5th 2020 with its most recent update done on October 10th 2022. 54 participants are required to be enrolled over a span of 12 medical centres."

Answered by AI

What are the principal aims of this clinical investigation?

"This clinical trial, lasting from Day 1 to 85 (SAD) or 113 (MD), strives to evaluate the frequency, severity, and root cause of adverse events correlated with treatment. Secondary goals include measuring MD AUCtau (Area under the curve over dosing interval tau for one week after starting and ending doses), SAD Dose Normalized Cmax, and SAD Dose Normalised AUCinf."

Answered by AI

What is the maximum capacity of participants in this clinical trial?

"To make this clinical trial a success, 54 persons that meet the stipulated requirements need to take part. These individuals can join from multiple sites such as University of Illinois at Chicago Clinical Research Center in New york City and Columbia University Medical Centre - Herbert Irving Pavilion located in Atlanta, Georgia."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
New York
Texas
How old are they?
18 - 65
What site did they apply to?
UT Physicians Comprehensive Sickle Cell Center Houston
Memorial Hermann clinical research unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Study said it will take place in NY. I try to give back doing medical studies to help people survive.
PatientReceived no prior treatments
I am interested in maintaining my good health and also receive payment for it.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Memorial Hermann clinical research unit: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
~10 spots leftby May 2025