How different doses of PF-07985631 affect and are tolerated by healthy adults.
A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE DOSE-ESCALATION AND MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-07985631 IN HEALTHY ADULT PARTICIPANTS
This study will test different doses of PF-07985631 or placebo in healthy adults to see how safe it is and how the drug behaves in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Brussels, Bruxelles-capitale, Région de) |
| Trial ID | NCT06994897 on ClinicalTrials.gov |
What this trial studies
This phase 1, randomized, placebo‑controlled study enrolls healthy adult volunteers to characterize the safety, tolerability, and pharmacokinetics of PF-07985631. Most participants receive a single subcutaneous injection or intravenous infusion, while selected cohorts receive monthly doses for three months. Clinical assessments and blood sampling are performed at the Pfizer Clinical Research Unit in Brussels to compare participants receiving PF-07985631 with those receiving placebo. Specific cohorts include Japanese/Chinese participants with ancestry requirements and an extended age limit up to 55 years for those cohorts.
Who should consider this trial
Good fit: Healthy adults aged 18–45 (up to 55 for Japanese/Chinese or multiple‑dose cohorts) with no significant medical history and who meet any ancestry criteria for the relevant cohorts are ideal candidates.
Not a fit: People with significant medical conditions, active or recent infections, a history of serious allergic reactions to biologics, or who do not meet the age or ancestry criteria are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify safe dose ranges and how PF-07985631 behaves in the body, enabling further testing in people with IgA nephropathy.
How similar studies have performed: Similar first‑in‑human Phase 1 trials of biologic agents have successfully characterized safety and pharmacokinetics, but PF-07985631 itself is being tested in humans under this protocol for initial safety and PK data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels, Bruxelles-capitale, Région de
- Pfizer Clinical Research Unit - Brussels — Brussels, Bruxelles-capitale, Région de, Belgium (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.