A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body in Healthy Adults
NCT ID: NCT07235150
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
76 participants
INTERVENTIONAL
2025-12-11
2027-07-27
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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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)
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
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
PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
Interventions
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PF-07985631
Experimental Pfizer compound which will be SC
Placebo
Placebo which will be SC
Eligibility Criteria
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Inclusion Criteria
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
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Q-Pharm Pty Ltd. (Nucleus Network)
Herston, Queensland, Australia
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5661003
Identifier Type: -
Identifier Source: org_study_id