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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519215-33-00 | Registry Identifier | CTIS (EU) |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: single ascending dose | Experimental | Dose A (3 active: 2 placebo) |
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| Cohort 2: single ascending dose | Experimental | Dose B (3 active: 2 placebo) |
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| Cohort 3: single ascending dose | Experimental | Dose C (6 active: 2 placebo) |
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| Cohort 4: single ascending dose | Experimental | Dose D (6 active: 2 placebo) |
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| Cohort 5: single ascending dose | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) |
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| Cohort 6: single ascending dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07985631 | Drug | Experimental Pfizer compound which will be SC or IV |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion:
Exclusion:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Recruiting | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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Optional Cohort with dose to be determined (6 active: 2 placebo)
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| Cohort 7: single ascending dose | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) |
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| Cohort 8: single dose | Experimental | Optional Japanese Cohort dose to be determined (4 active: 1 placebo) |
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| Cohort 9: single dose | Experimental | Optional Chinese Cohort dose to be determined (4 active: 1 placebo) |
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| Cohort 10: multiple dose | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) |
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| Cohort 11 | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) |
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| Cohort 12 | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) |
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| Cohort 13 | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) |
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| Placebo | Drug | Placebo which will be SC or IV |
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| 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) |
| Plasma Decay Half-Life (t1/2): SAD cohorts only | Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months) |