Actively Recruiting
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body in Healthy Adults
Led by Pfizer · Updated on 2026-03-19
76
Participants Needed
1
Research Sites
88 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) at the study clinic. Most participants will receive PF-07985631 or placebo one time. Some participants may receive PF-07985631 or placebo twice. 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 will take part in this study for about four- four and a half months. During this time, they will stay at the study clinic for 12 to 19 days and will have 7 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 in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 45 years of age who are overtly healthy.
- For Japanese and Chinese participants only: adults between 18 and 55 years of age.
- For Japanese and Chinese participants only: 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, symptom-free seasonal allergies).
- History of allergic or severe reaction to investigational biological drugs.
- Infection requiring treatment within 28 days before Day 1 or any active infection at Day 1.
- Active or latent tuberculosis infection.
- History of repeated urinary tract, sinopulmonary, or gastrointestinal infections needing antibiotics.
- Known fever within 7 days before dosing.
- Active stomach ulcers or bleeding.
- Vaccination within 6 weeks before Day 1 or planned vaccination during the study.
- Positive urine drug test.
- Blood pressure at screening of systolic ≥140 mm Hg or diastolic ≥90 mm Hg.
- Estimated kidney filtration rate below 75 mL/min/1.73 m².
- Chest X-ray showing active chest disease, unresolved lung nodules over 0.5 cm, cavitary lesions, or bronchiectasis.
- ECG with clinically relevant abnormalities affecting safety or study results.
- Positive stool blood test at screening or admission.
- Abnormal laboratory test values 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
Q-Pharm Pty Ltd. (Nucleus Network)
Herston, Queensland, Australia, 4006
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
11
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