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TerminatedNCT07235150Updated Aug 18, 2026

A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body in Healthy Adults

A Phase 1 interventional study of PF-07985631 and Placebo in Healthy, sponsored by Pfizer. Terminated at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Why this study was terminated
The estimated benefit-risk profile of PF-07985631 is not anticipated to be favorable in the expected population to be treated
Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy

Keywords

  • healthy participants
  • healthy volunteers
  • safety
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  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 criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Cohort 1 Dose A (3 active: 2 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be subcutaneous (SC)

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 8 Optional Cohort with dose to be determined, Japanese (4 active: 1 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 7 Dose G (6 active: 2 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 6 Dose F (6 active: 2 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 2 Dose B (3 active: 2 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 4 Dose D (6 active: 2 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 5 Dose E (6 active: 2 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 9 Optional Cohort with dose to be determined, Chinese (4 active: 1 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 3 Dose C (6 active: 2 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 10 Optional Cohort with dose to be determined (6 active: 2 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

  • Experimental
    Cohort 11 Optional Cohort with dose to be determined (6 active: 2 placebo)

    Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC

    Drug: PF-07985631 · Drug: Placebo

Interventions

  • DrugPF-07985631

    Experimental Pfizer compound which will be SC

  • DrugPlacebo

    Placebo which will be SC

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)

    Time frame: Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)

  2. Number of Participants With Clinically Significant Abnormal Laboratory Parameters

    Time frame: Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)

  3. Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria

    Time frame: Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)

  4. Number of Participants With Notable Electrocardiogram (ECG) Values

    Time frame: Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) as data permit

    Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) as data permit

    Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)

  3. Maximum Observed Plasma Concentration (Cmax) as data permit

    Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) as data permit

    Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)

  5. Plasma Decay Half-Life (t1/2) as data permit

    Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)

07

Study locations

1 site
  • Q-Pharm Pty Ltd. (Nucleus Network)
    Herston, Queensland 4006, Australia
08

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07235150
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 19, 2025
Start date
Dec 11, 2025
Primary completion
Jul 16, 2026
Completion
Jul 16, 2026
Last update
Aug 18, 2026

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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