A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED EVALUATION OF SINGLE DOSES OF PF-07209326 IN HEALTHY PARTICIPANTS (SAFETY, TOLERABILITY, AND PHARMACOKINETICS [PK]) FOLLOWED BY AN OPEN LABEL, REPEAT DOSE EVALUATION IN SICKLE CELL DISEASE PARTICIPANTS (SAFETY, TOLERABILITY, PK AND EFFICACY)

About the study

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.

Study point of contact

Pfizer CT.gov Call Center
1-800-718-1021
[email protected]

Locations

13 United States sites

Age

18 Years - 55 Years

Phase

Phase 1

Study type

Interventional

Gender

All

Interventions

Biological

participation requirements

Health Participants:

1. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

participation restrictions

Healthy Participants:

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:

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.
Participants with a history of allergic or anaphylactic reaction to therapeutic or diagnostic protein.
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.

Locations

  • New Haven, Connecticut, United States, New Haven Clinical Research Unit
  • Washington, District of Columbia, United States, Howard University College of Medicine
  • Fort Myers, Florida, United States, Golisano Children's Hospital of Southwest Florida
  • Fort Myers, Florida, United States, Lee Health - Golisano Children's Hospital of Southwest Florida
  • Atlanta, Georgia, United States, Children's Healthcare of Atlanta - Egleston Hospital-Aflac Cancer and Blood Disorders Center
  • Chicago, Illinois, United States, University of Illinois at Chicago Clinical Research Center
  • Chicago, Illinois, United States, University of Illinois at Chicago
  • Saint Paul, Minnesota, United States, Prism Research LLC dba Nucleus Network
  • New York, New York, United States, Columbia University Medical Center - Herbert Irving Pavilion
  • New York, New York, United States, Columbia University Medical Center
  • New York, New York, United States, CUMC Research Pharmacy
  • Houston, Texas, United States, UT Physicians Comprehensive Sickle Cell Center Houston
  • Houston, Texas, United States, Memorial Hermann clinical research unit
Last updated 2022-09-22