Status:
RECRUITING
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07985631) for the possible treatment of a kidney disease called IgA nephropathy. This study is seek...
Eligibility Criteria
Inclusion
- Inclusion:
- Between 18 and 45 years of age who are overtly healthy.
- Japanese/Chinese and multiple dose cohorts only: Adult participants 18 to 55 years of age who are overtly healthy may be eligible at the discretion of PI.
- Japanese/Chinese cohorts only: Participants must have 4 biological Japanese/Chinese grandparents who were born in Japan/China.
- Exclusion:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Participants with a history of allergic or anaphylactic reaction with any investigative biologic agents.
- History of infections requiring treatment within 28 days prior to Day 1 or any active infection at Day 1.
- Active or latent infection with tuberculosis.
- History of recurrent urinary tract infections AND/OR sinopulmonary infections AND/OR gastrointestinal infections requiring antibiotic treatment.
- Known fever within the 7 days prior to dosing.
- Active gastrointestinal (GI) tract ulcerations or GI bleeding.
- Vaccination within 6 weeks prior to Day 1 dosing or planned vaccination during the study.
- Positive urine drug test.
- Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic).
- Estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m².
- Chest X-ray showing any active disease in the chest, or pulmonary nodules \>0.5 cm in diameter that have not been previously evaluated, cavitary lesions or evidence of bronchiectasis.
- Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
- Positive stool hematest at screening or admission.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (direct and total) ≥1.05 × upper limit of normal
- Immunoglobulin G, Immunoglobulin M, Immunoglobulin A below the lower limit of normal (LLN)
- Total white blood cell (WBC) below the LLN
- Lymphocyte count below the LLN
- Platelet count below the LLN
- Hemoglobin below the LLN
Exclusion
Key Trial Info
Start Date :
August 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2027
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06994897
Start Date
August 13 2025
End Date
December 8 2027
Last Update
December 2 2025
Active Locations (1)
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1
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070