Pfizer launches early safety trial for potential IgA nephropathy treatment
NCT ID NCT07235150
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This early-stage study tests a new medicine, PF-07985631, in healthy adults to check its safety and how the body processes it. The medicine is being developed for a kidney disease called IgA nephropathy. Participants receive either the drug or a placebo as a single injection and are monitored for about four months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Dec 2025
- Finished
-
Jul 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion: 1. Between 18 and 45 years of age who are overtly healthy. 2. Japanese/Chinese cohorts only: Adult participants 18 to 55 years of age 3. Japanese/Chinese cohorts only: Participants must have 4 biological Japanese/Chinese grandparents who were born in Japan/China. Exclusion: 1. 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). 2. Participants with a history of allergic or anaphylactic reaction with any investigative biologic agents. 3. History of infections requiring treatment within 28 days prior to Day 1 or any active infection at Day 1. 4. Active or latent infection with tuberculosis. 5. History of recurrent urinary tract infections AND/OR sinopulmonary infections AND/OR gastrointestinal infections requiring antibiotic treatment. 6. Known fever within the 7 days prior to dosing. 7. Active gastrointestinal (GI) tract ulcerations or GI bleeding. 8. Vaccination within 6 weeks prior to Day 1 dosing or planned vaccination during the study. 9. Positive urine drug test. 10. Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic). 11. Estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m². 12. 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. 13. Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. 14. Positive stool hematest at screening or admission. 15. 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Q-Pharm Pty Ltd. (Nucleus Network)
Herston, Queensland, 4006, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a chewable postbiotic tablet keep plaque and gum inflammation at bay?
- Can a new oral drug safely help older adults manage weight?
- Can a protein powder with creatine and fiber boost everyday Well-Being?
- Green tech or hidden stress? bus Drivers' hearts monitored behind the wheel
- Shout it out: can growls and screams raise pain tolerance?
- Scientists probe why brain stimulation works for some and not others