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RECRUITING Phase 1 ClinicalTrials.gov

A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy Adults

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07235163

Registry updated: 2026-08-24
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Description

The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08065010) for possible treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). This study is seeking participants who are: * male or female between 18 and 65 years of age * deemed to be healthy Participants in this study will receive PF-08065010 or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-08065010 or placebo will be given as a shot (in the abdomen, thigh or back of the arms) or as an IV infusion in the arm (given directly into a vein) at the study clinic. In Part A, participants will take PF-08065010 or placebo only 1 time and will take part in this study for about 5 months. During this time, they will stay at the study clinic for about 9-10 days and will have about 6 more study visits at the study clinic. Participants in Part B of the study will take PF-08065010 or placebo once a month, for 3 months and will take part in this study for about 7 months. During this time, they will stay at the study clinic for about 4 days each month and will have about 6 more study visits at the study clinic. During study clinic stays and study visits, urine, blood samples, and physical exams will be done.

Interventions

  • PF-08065010 (Drug)
    Experimental Pfizer compound which will be subcutaneous (SC) or intravenous (IV).
  • Placebo (Drug)
    Placebo which will be SC or IV

Eligibility criteria

Inclusion Criteria: * male or female between 18 and 65 years of age * deemed to be healthy Exclusion Criteria: 1. Evidence or history of clinically significant medical conditions. 2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg)or hepatitis C antibody (HCVAb). 3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. 4. A positive urine drug test.

Conditions

Healthy

Locations

  • Pfizer Clinical Research Unit - Brussels — Brussels, Bruxelles-capitale, Région de, Belgium
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record