HealthyPhase 1NCT06994897
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
A Phase 1 study testing PF-07985631 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-07985631
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Aug 2025to 8 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE DOSE-ESCALATION AND MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-07985631 IN HEALTHY ADULT PARTICIPANTS
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
Read more
- 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.
- Conditions
- Healthy
- Being tested
- PF-07985631, Placebo
- Keywords
- healthy participant, healthy volunteers, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07985631Drug
Experimental Pfizer compound which will be SC or IV
PlaceboDrug
Placebo which will be SC or IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: single ascending dose | Experimental | Dose A (3 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 2: single ascending dose | Experimental | Dose B (3 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 3: single ascending dose | Experimental | Dose C (6 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 4: single ascending dose | Experimental | Dose D (6 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 5: single ascending dose | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 6: single ascending dose | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 7: single ascending dose | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 8: single dose | Experimental | Optional Japanese Cohort dose to be determined (4 active: 1 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 9: single dose | Experimental | Optional Chinese Cohort dose to be determined (4 active: 1 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 10: multiple dose | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 11 | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 12 | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
| Cohort 13 | Experimental | Optional Cohort with dose to be determined (6 active: 2 placebo) Receives: Drug: PF-07985631; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Maximum Observed Plasma Concentration (Cmax)
Measured: 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)
Measured: 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
Measured: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start13 Aug 2025
- Primary completion8 Dec 2027 (estimated)
- Study completion8 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994897
- Sponsor's protocol ID
- C5661001
- Other IDs
- 2024-519215-33-00
- Status last verified
- Mar 2026
- First submitted
- 20 May 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE DOSE-ESCALATION AND MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-07985631 IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06994897
- Acronym / sponsor ID
- C5661001
- Conditions
- Healthy
- Keywords
- healthy participant, healthy volunteers, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 8 Dec 2027 (estimated)
- Study completion
- 8 Dec 2027 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: single ascending dose | Experimental | Drug: PF-07985631, Drug: PlaceboDose A (3 active: 2 placebo) |
| Cohort 2: single ascending dose | Experimental | Drug: PF-07985631, Drug: PlaceboDose B (3 active: 2 placebo) |
| Cohort 3: single ascending dose | Experimental | Drug: PF-07985631, Drug: PlaceboDose C (6 active: 2 placebo) |
| Cohort 4: single ascending dose | Experimental | Drug: PF-07985631, Drug: PlaceboDose D (6 active: 2 placebo) |
| Cohort 5: single ascending dose | Experimental | Drug: PF-07985631, Drug: PlaceboOptional Cohort with dose to be determined (6 active: 2 placebo) |
| Cohort 6: single ascending dose | Experimental | Drug: PF-07985631, Drug: PlaceboOptional Cohort with dose to be determined (6 active: 2 placebo) |
| Cohort 7: single ascending dose | Experimental | Drug: PF-07985631, Drug: PlaceboOptional Cohort with dose to be determined (6 active: 2 placebo) |
| Cohort 8: single dose | Experimental | Drug: PF-07985631, Drug: PlaceboOptional Japanese Cohort dose to be determined (4 active: 1 placebo) |
| Cohort 9: single dose | Experimental | Drug: PF-07985631, Drug: PlaceboOptional Chinese Cohort dose to be determined (4 active: 1 placebo) |
| Cohort 10: multiple dose | Experimental | Drug: PF-07985631, Drug: PlaceboOptional Cohort with dose to be determined (6 active: 2 placebo) |
| Cohort 11 | Experimental | Drug: PF-07985631, Drug: PlaceboOptional Cohort with dose to be determined (6 active: 2 placebo) |
| Cohort 12 | Experimental | Drug: PF-07985631, Drug: PlaceboOptional Cohort with dose to be determined (6 active: 2 placebo) |
| Cohort 13 | Experimental | Drug: PF-07985631, Drug: PlaceboOptional Cohort with dose to be determined (6 active: 2 placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07985631Experimental Pfizer compound which will be SC or IV | Drug | Cohort 10: multiple dose, Cohort 11, Cohort 12, Cohort 13, Cohort 1: single ascending dose, Cohort 2: single ascending dose, Cohort 3: single ascending dose, Cohort 4: single ascending dose, Cohort 5: single ascending dose, Cohort 6: single ascending dose, Cohort 7: single ascending dose, Cohort 8: single dose, Cohort 9: single dose |
| PlaceboPlacebo which will be SC or IV | Drug | Cohort 10: multiple dose, Cohort 11, Cohort 12, Cohort 13, Cohort 1: single ascending dose, Cohort 2: single ascending dose, Cohort 3: single ascending dose, Cohort 4: single ascending dose, Cohort 5: single ascending dose, Cohort 6: single ascending dose, Cohort 7: single ascending dose, Cohort 8: single dose, Cohort 9: single dose |
Primary outcome
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 4.5 months)
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 4.5 months)
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 4.5 months)
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 4.5 months)
6 secondary outcomes
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): MD cohorts only
Time frame: 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
Time frame: 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
Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Maximum Observed Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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
Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07985631 in people with Healthy, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 4.5 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.