Different amounts of PF-07985631: how healthy adults tolerate it and how it acts in the body

A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-07985631 IN HEALTHY ADULT PARTICIPANTS

This trial will test different doses of PF-07985631 in healthy adults to see if the drug is safe and how it behaves in the body for a possible future treatment of IgA nephropathy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Pfizer (Industry-sponsored)
• Locations: 1 site (Herston, Queensland)
• Trial ID: NCT07235150 on ClinicalTrials.gov

What this trial studies

This Phase 1, placebo-controlled study gives single or, for some cohorts, two small injections of PF-07985631 or placebo to healthy adult volunteers to gather safety and pharmacokinetic data. Most participants receive one dose, while some cohorts (including specific Japanese/Chinese groups) may receive a second dose and have an upper age limit of 55. Volunteers are screened to exclude significant medical conditions, recent or active infections, and prior severe allergic reactions before dosing at a clinical research unit. The data will inform safe dose ranges and whether the drug should move into patient trials for IgA nephropathy.

Who should consider this trial

Good fit: Healthy adults aged 18–45 (up to 55 for the Japanese/Chinese cohorts) with no significant medical history, no recent or active infections, and no history of severe allergic reactions are ideal candidates.

Not a fit: People with active or chronic medical conditions, recent infections, a history of severe allergic reactions to biologic agents, or those seeking immediate therapeutic benefit are unlikely to be eligible or to receive direct medical benefit from participating.

Why it matters

Potential benefit: If successful, this work could identify safe doses and how PF-07985631 behaves in the body, enabling development of a potential new treatment for IgA nephropathy.

How similar studies have performed: Placebo-controlled Phase 1 dosing studies in healthy volunteers are a standard early step that have successfully guided dosing for many later-stage drug trials, but PF-07985631 itself is at an early, unproven stage.

Eligibility criteria

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

Where this trial is running

Herston, Queensland

• Q-Pharm Pty Ltd. (Nucleus Network) — Herston, Queensland, Australia (Recruiting)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions Healthy; healthy participants; healthy volunteers; safety