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Pfizer launches early safety trial for new kidney disease drug

NCT ID NCT06994897

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new medicine called PF-07985631, which may one day treat a kidney disease called IgA nephropathy. About 92 healthy adults will receive either the study drug or a placebo as an injection or IV. The main goal is to check safety and how the body processes the drug, not to treat any illness.

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

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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

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 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. 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pfizer Clinical Research Unit - Brussels

    RECRUITING

    Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

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