Actively 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
Led by Pfizer · Updated on 2026-03-20
92
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 seeking participants who * are male or female between 18 and 45 years of age (55 for Japanese/Chinese/multiple dose participants) * are deemed to be healthy Participants in this study will receive PF-07985631 or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07985631 or placebo will be given as a small needle injection (in the abdomen, thigh or back of the arm) or as an IV infusion in the arm (given directly into a vein) at the study clinic. Most participants will receive PF-07985631 or placebo one time. Some participants may receive PF-07985631 or placebo once a month for 3 months. The study will compare the experiences of people receiving PF-07985631 to those of the people who do not. This will help decide if PF-07985631 is safe and effective. Participants who take PF-07985631 or placebo only 1 time will take part in this study for about 4 months. During this time, they will stay at the study clinic for 11 to 14 days and will have 8 more study visits at the study clinic. Participants who take PF-07985631 or placebo more than once will take part in this study for about 6 months. During this time, they will stay at the study clinic for about 4 days a month 3 times and will have 10 more study visits at the study clinic. During study clinic stays and study visits, blood samples will be done and safety reviews completed.
CONDITIONS
Official Title
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 45 years of age and overtly healthy
- For Japanese/Chinese and multiple dose groups: adults 18 to 55 years of age and overtly healthy, at the discretion of the principal investigator
- Japanese/Chinese participants must have four biological grandparents born in Japan or China
You will not qualify if you...
- History or evidence of significant blood, kidney, hormone, lung, stomach, heart, liver, mental health, nerve, or allergy diseases (except untreated, asymptomatic seasonal allergies at dosing)
- History of allergic or anaphylactic reaction to investigational biologic agents
- Infection requiring treatment within 28 days before Day 1 or active infection at Day 1
- Active or latent tuberculosis infection
- History of recurrent urinary tract, sinopulmonary, or gastrointestinal infections needing antibiotics
- Fever within 7 days before dosing
- Active gastrointestinal ulcers or bleeding
- Vaccination within 6 weeks before Day 1 or planned vaccination during study
- Positive urine drug test
- Blood pressure 140/90 mm Hg or higher at screening
- Estimated glomerular filtration rate below 75 mL/min/1.73 m²
- Chest X-ray showing active chest disease, large lung nodules, cavitary lesions, or bronchiectasis
- Abnormal ECG that may affect safety or study results
- Positive stool blood test at screening or admission
- Abnormal lab tests including elevated liver enzymes, low immunoglobulins, low white blood cells, low lymphocytes, low platelets, or low hemoglobin
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
13
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