Dose Escalation Study of PF-07209326 in Healthy Participants

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Pfizer
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Updated on 16 February 2024
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Summary

This Phase 1 first-in-human 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.

Details
Condition Healthy
Age 18years - 55years
Treatment Placebo, PF-07209326
Clinical Study IdentifierNCT04255875
SponsorPfizer
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

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
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
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