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

NCT07235150 | Recruiting Phase 1

• 1 other identifier: C5661003
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Healthy

Keywords

healthy participants; healthy volunteers; safety

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 3 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 3 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 3 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 3 months)

Secondary Outcomes (5)

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

  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 Extrapolated Infinite Time (AUCinf) as data permit

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

• Maximum Observed Plasma Concentration (Cmax) as data permit

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

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

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

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

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

Study Arms (11)

Cohort 1 Dose A (3 active: 2 placebo)

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

Cohort 2 Dose B (3 active: 2 placebo)

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

Cohort 3 Dose C (6 active: 2 placebo)

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

Cohort 4 Dose D (6 active: 2 placebo)

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

Cohort 5 Dose E (6 active: 2 placebo)

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

Cohort 6 Dose F (6 active: 2 placebo)

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

Cohort 7 Dose G (6 active: 2 placebo)

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

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

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

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

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

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

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

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

EXPERIMENTAL

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

Drug: PF-07985631; Drug: Placebo

Interventions

PF-07985631 DRUG

Experimental Pfizer compound which will be SC

Cohort 1 Dose A (3 active: 2 placebo); Cohort 10 Optional Cohort with dose to be determined (6 active: 2 placebo); Cohort 11 Optional Cohort with dose to be determined (6 active: 2 placebo); Cohort 2 Dose B (3 active: 2 placebo); Cohort 3 Dose C (6 active: 2 placebo); Cohort 4 Dose D (6 active: 2 placebo); Cohort 5 Dose E (6 active: 2 placebo); Cohort 6 Dose F (6 active: 2 placebo); Cohort 7 Dose G (6 active: 2 placebo); Cohort 8 Optional Cohort with dose to be determined, Japanese (4 active: 1 placebo); Cohort 9 Optional Cohort with dose to be determined, Chinese (4 active: 1 placebo)

Placebo DRUG

Placebo which will be SC

Cohort 1 Dose A (3 active: 2 placebo); Cohort 10 Optional Cohort with dose to be determined (6 active: 2 placebo); Cohort 11 Optional Cohort with dose to be determined (6 active: 2 placebo); Cohort 2 Dose B (3 active: 2 placebo); Cohort 3 Dose C (6 active: 2 placebo); Cohort 4 Dose D (6 active: 2 placebo); Cohort 5 Dose E (6 active: 2 placebo); Cohort 6 Dose F (6 active: 2 placebo); Cohort 7 Dose G (6 active: 2 placebo); Cohort 8 Optional Cohort with dose to be determined, Japanese (4 active: 1 placebo); Cohort 9 Optional Cohort with dose to be determined, Chinese (4 active: 1 placebo)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 45 years of age who are overtly healthy.
• Japanese/Chinese cohorts only: Adult participants 18 to 55 years of age
• 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:

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Q-Pharm Pty Ltd. (Nucleus Network)

Herston, Queensland, 4006, Australia

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): August 24, 2027
• Study Completion (Estimated): August 24, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)