NCT06994897

Brief 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) or as an IV infusion in the arm (given directly into a vein) at the study clinic. Most participants will receive PF-07985631 or placebo one time. Some participants may receive PF-07985631 or placebo once a month for 3 months. 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 only 1 time will take part in this study for about 4 months. During this time, they will stay at the study clinic for 11 to 14 days and will have 8 more study visits at the study clinic. Participants who take PF-07985631 or placebo more than once will take part in this study for about 6 months. During this time, they will stay at the study clinic for about 4 days a month 3 times and will have 10 more study visits at the study clinic. During study clinic stays and study visits, blood samples will be done and safety reviews completed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1 healthy

Timeline
19mo left

Started Aug 2025

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 13, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

May 20, 2025

Last Update Submit

March 18, 2026

Conditions

Healthy

Keywords

healthy participanthealthy volunteerssafety

Outcome Measures

Primary Outcomes (4)

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

    Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)

  • Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria

    Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)

  • Number of Participants With Notable Electrocardiogram (ECG) Values

    Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)

  • Number of Participants With Clinically Significant Abnormal Laboratory Parameters

    Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)

Secondary Outcomes (6)

  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): MD cohorts only

    Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): SAD cohorts only

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

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): SAD cohorts only

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

  • Maximum Observed Plasma Concentration (Cmax)

    Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)

  • +1 more secondary outcomes

Study Arms (13)

Cohort 1: single ascending dose

EXPERIMENTAL

Dose A (3 active: 2 placebo)

Drug: PF-07985631Drug: Placebo

Cohort 2: single ascending dose

EXPERIMENTAL

Dose B (3 active: 2 placebo)

Drug: PF-07985631Drug: Placebo

Cohort 3: single ascending dose

EXPERIMENTAL

Dose C (6 active: 2 placebo)

Drug: PF-07985631Drug: Placebo

Cohort 4: single ascending dose

EXPERIMENTAL

Dose D (6 active: 2 placebo)

Drug: PF-07985631Drug: Placebo

Cohort 5: single ascending dose

EXPERIMENTAL

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

Drug: PF-07985631Drug: Placebo

Cohort 6: single ascending dose

EXPERIMENTAL

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

Drug: PF-07985631Drug: Placebo

Cohort 7: single ascending dose

EXPERIMENTAL

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

Drug: PF-07985631Drug: Placebo

Cohort 8: single dose

EXPERIMENTAL

Optional Japanese Cohort dose to be determined (4 active: 1 placebo)

Drug: PF-07985631Drug: Placebo

Cohort 9: single dose

EXPERIMENTAL

Optional Chinese Cohort dose to be determined (4 active: 1 placebo)

Drug: PF-07985631Drug: Placebo

Cohort 10: multiple dose

EXPERIMENTAL

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

Drug: PF-07985631Drug: Placebo

Cohort 11

EXPERIMENTAL

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

Drug: PF-07985631Drug: Placebo

Cohort 12

EXPERIMENTAL

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

Drug: PF-07985631Drug: Placebo

Cohort 13

EXPERIMENTAL

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

Drug: PF-07985631Drug: Placebo

Interventions

PF-07985631DRUG

Experimental Pfizer compound which will be SC or IV

Cohort 10: multiple doseCohort 11Cohort 12Cohort 13Cohort 1: single ascending doseCohort 2: single ascending doseCohort 3: single ascending doseCohort 4: single ascending doseCohort 5: single ascending doseCohort 6: single ascending doseCohort 7: single ascending doseCohort 8: single doseCohort 9: single dose
PlaceboDRUG

Placebo which will be SC or IV

Cohort 10: multiple doseCohort 11Cohort 12Cohort 13Cohort 1: single ascending doseCohort 2: single ascending doseCohort 3: single ascending doseCohort 4: single ascending doseCohort 5: single ascending doseCohort 6: single ascending doseCohort 7: single ascending doseCohort 8: single doseCohort 9: single dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 45 years of age who are overtly healthy.
  • 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.
  • Japanese/Chinese cohorts only: Participants must have 4 biological Japanese/Chinese grandparents who were born in Japan/China.

You may not qualify if:

  • 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).
  • Participants with a history of allergic or anaphylactic reaction with any investigative biologic agents.
  • History of infections requiring treatment within 28 days prior to Day 1 or any active infection at Day 1.
  • Active or latent infection with tuberculosis.
  • History of recurrent urinary tract infections AND/OR sinopulmonary infections AND/OR gastrointestinal infections requiring antibiotic treatment.
  • Known fever within the 7 days prior to dosing.
  • Active gastrointestinal (GI) tract ulcerations or GI bleeding.
  • Vaccination within 6 weeks prior to Day 1 dosing or planned vaccination during the study.
  • Positive urine drug test.
  • Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic).
  • Estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m².
  • 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.
  • Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • Positive stool hematest at screening or admission.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening:
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

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

RECRUITING

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

August 13, 2025

Primary Completion (Estimated)

December 8, 2027

Study Completion (Estimated)

December 8, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

BE(1)