Healthy ParticipantsPhase 1NCT06003777

A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults

A Phase 1 study testing PF-06954522 in people with Healthy Participants, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purposes of this study are: To see how the new medicine (PF-06954522) under study behave. And if there are any important side effects. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: PF-06954522
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 30 Aug 2023to 20 Feb 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
BMI of 16 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

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).
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention, with the exception of moderate or strong cytochrome P450 3A (CYP3A) inducers or inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73 m².
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

Show all 12Show fewer

Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin
1.05 × upper limit of normal (ULN);
TSH > ULN;
HbA1c ≥6.5%;
Hematuria as defined by ≥1+ heme on urine dipstick;
Albuminuria as defined by urine albumin/creatinine ratio (UACR) >30 mg/g.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, CROSSOVER, FIRST-IN-HUMAN STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-06954522 IN HEALTHY ADULT PARTICIPANTS

The purposes of this study are:

To see how the new medicine (PF-06954522) under study behave. And if there are any important side effects. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. The study will see how people feel after taking single increasing amount of the medicine by mouth.
To measure the amount of study medicine in your blood after the medicine is taken by mouth.

This study is seeking for participants who:

are females of 18 to 65 years old and are not able to give birth to a child.
are males of 18 to 65 years old.
have body mass index of 16 to 31 kilograms per meter squared.
have a total body weight of more than 50 kilograms (110 pounds).

Participants will be chosen by chance, like drawing names out of a hat to receive either:

study medicine (PF-06954522)
or placebo (a pill that has no medicine in it).

Participants may receive up to 4 amounts of study medicine and up to 2 amounts of placebo. The time frame of the study is approximately up to 36 days for each group and participants will stay at CRU for 20 days.

Conditions: Healthy Participants
Being tested: PF-06954522, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06954522Drug
PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.
PlaceboDrug
Placebo will be administered as oral suspensions as escalating single doses to be determined.

Study groups in NCT06003777
Study group	Role	What they receive
Cohort 1	Experimental	Single dose administration of PF-06954522 and placebo. Participants will receive up to 5 dose levels of PF-06954522 and up to 2 dose levels of matching placebo. Receives: Drug: PF-06954522; Drug: Placebo
Cohort 2	Experimental	Single dose administration of PF-06954522 and placebo. Participants will receive up to 4 dose levels of PF-06954522 and up to 2 dose levels of matching placebo. Receives: Drug: PF-06954522; Drug: Placebo
Cohort 3	Experimental	Single dose administration of PF-06954522 and placebo. Participants will receive up to 2 dose levels of PF-06954522 and up to 1 dose level of matching placebo. Receives: Drug: PF-06954522; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AEs) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With TEAEs
An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With TEAEs
An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg and increase or decrease from baseline >= 20mmHg.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
Measured: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)

Secondary outcomes (10)

Cohort 1: Area Under the Plasma Concentration-Time Profile From Time Zero (0) to Time of Last Quantifiable Concentration (AUClast) of PF-06954522
AUClast was determined by using linear/log trapezoidal method.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: AUClast of PF-06954522
AUClast was determined by using linear/log trapezoidal method.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Maximum Observed Concentration (Cmax) of PF-06954522
Cmax of PF-06954522 was reported in this outcome measure.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: Cmax of PF-06954522
Cmax of PF-06954522 was reported in this outcome measure.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Time to Maximum Observed Concentration (Tmax) of PF-06954522
Tmax of PF-06954522 was reported in this outcome measure.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: Tmax of PF-06954522
Tmax of PF-06954522 was reported in this outcome measure.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of PF-06954522
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: AUCinf of PF-06954522
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Terminal Half-Life (t1/2) of PF-06954522
t1/2 was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: t1/2 of PF-06954522
t1/2was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202320 Feb 2024

First posted22 Aug 2023
Study start30 Aug 2023
Primary completion20 Feb 2024
Study completion20 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies 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: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06003777
Sponsor's protocol ID: C4001001
Other IDs: NCT06003777
Status last verified: Jun 2025
First submitted: 3 Aug 2023
Last updated: 24 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, CROSSOVER, FIRST-IN-HUMAN STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-06954522 IN HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT06003777
Acronym / sponsor ID: C4001001
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 30 Aug 2023 (actual)
Primary completion: 20 Feb 2024 (actual)
Study completion: 20 Feb 2024 (actual)
First posted: 22 Aug 2023 (actual)
Results: Posted 24 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purposes of this study are:

To see how the new medicine (PF-06954522) under study behave. And if there are any important side effects. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. The study will see how people feel after taking single increasing amount of the medicine by mouth.
To measure the amount of study medicine in your blood after the medicine is taken by mouth.

This study is seeking for participants who:

are females of 18 to 65 years old and are not able to give birth to a child.
are males of 18 to 65 years old.
have body mass index of 16 to 31 kilograms per meter squared.
have a total body weight of more than 50 kilograms (110 pounds).

Participants will be chosen by chance, like drawing names out of a hat to receive either:

study medicine (PF-06954522)
or placebo (a pill that has no medicine in it).

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1	Experimental	Drug: PF-06954522, Drug: PlaceboSingle dose administration of PF-06954522 and placebo. Participants will receive up to 5 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.
Cohort 2	Experimental	Drug: PF-06954522, Drug: PlaceboSingle dose administration of PF-06954522 and placebo. Participants will receive up to 4 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.
Cohort 3	Experimental	Drug: PF-06954522, Drug: PlaceboSingle dose administration of PF-06954522 and placebo. Participants will receive up to 2 dose levels of PF-06954522 and up to 1 dose level of matching placebo.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
BMI of 16 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Key exclusion criteria (12 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).
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention, with the exception of moderate or strong cytochrome P450 3A (CYP3A) inducers or inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73 m².

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-06954522PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.	Drug	Cohort 1, Cohort 2, Cohort 3
PlaceboPlacebo will be administered as oral suspensions as escalating single doses to be determined.	Drug	Cohort 1, Cohort 2, Cohort 3

Primary outcome

Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
An adverse event (AEs) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Cohort 2: Number of Participants With TEAEs
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Cohort 3: Number of Participants With TEAEs
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Cohort 1: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Cohort 2: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Cohort 3: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Cohort 1: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Cohort 2: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Cohort 3: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Cohort 1: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Cohort 2: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Cohort 3: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.
Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.
Cohort 3: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg and increase or decrease from baseline >= 20mmHg.
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.

10 secondary outcomes

Cohort 1: Area Under the Plasma Concentration-Time Profile From Time Zero (0) to Time of Last Quantifiable Concentration (AUClast) of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: AUClast of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Maximum Observed Concentration (Cmax) of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: Cmax of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Time to Maximum Observed Concentration (Tmax) of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: Tmax of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: AUCinf of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Terminal Half-Life (t1/2) of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: t1/2 of PF-06954522
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Results and safety

Results posted to the registry on 24 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Sequence 1	2	2
Cohort 1: Sequence 2	1	1
Cohort 1: Sequence 3	2	1
Cohort 1: Sequence 4	2	2
Cohort 1: Sequence 5	2	1
Cohort 2: Sequence 1	2	2
Cohort 2: Sequence 2	2	2
Cohort 2: Sequence 3	2	2
Cohort 2: Sequence 4	2	2
Cohort 3: Sequence 1	2	2
Cohort 3: Sequence 2	2	2
Cohort 3: Sequence 3	2	2

Primary outcome: Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days). Count of participants. Unit: Participants

Measure	Cohort 1: PF-06954522 Dose Level C n = 7	Cohort 1: PF-06954522 Dose Level D n = 8	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n = 8	Cohort 1: PF-06954522 Dose Level E n = 8	Cohort 1: PF-06954522 Dose Level F n = 6	Cohort 1 and 2: Placebo (Fasted State) n = 11	Cohort 1 and 2: Placebo (Fed State) n = 4
Value	5	8	6	8	6	3	1

Population analysed: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Primary outcome: Cohort 2: Number of Participants With TEAEs

Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days). Count of participants. Unit: Participants

Measure	Cohort 1 and 2: Placebo (Fasted State) n = 11	Cohort 2: Placebo (Fed-standard Meal) n = 2	Cohort 1 and 2: Placebo (Fed-high Fat Meal) n = 4	Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal) n = 6	Cohort 2: PF-06954522 Dose Level B n = 6	Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal) n = 4	Cohort 2: PF-06954522 Dose Level F n = 5
Value	3	0	1	2	2	0	5

Population analysed: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Primary outcome: Cohort 3: Number of Participants With TEAEs

Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days). Count of participants. Unit: Participants

Measure	Cohort 3: Placebo n = 4	Cohort 3: Placebo (Fed) n = 2	Cohort 3: PF-06954522 Dose Level D n = 4	Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal) n = 4	Cohort 3: PF-06954522 Dose Level E n = 3
Value	3	2	4	4	3

Population analysed: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Primary outcome: Cohort 1: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days). Count of participants. Unit: Participants

Measure	Cohort 1: PF-06954522 Dose Level C n = 7	Cohort 1: PF-06954522 Dose Level D n = 8	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal n = 8	Cohort 1: PF-06954522 Dose Level E n = 8	Cohort 1: PF-06954522 Dose Level F n = 6	Cohort 1 and 2: Placebo (Fasted State) n = 11	Cohort 1 and 2: Placebo (Fed State) n = 4
Value	0	0	3	2	1	3	2

Population analysed: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 and 2: Placebo (Fasted State)	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Cohort 1 and 2: Placebo (Fed State)	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Cohort 1: PF-06954522 Dose Level C	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
Cohort 1: PF-06954522 Dose Level D	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal)	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Cohort 1: PF-06954522 Dose Level E	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Cohort 1: PF-06954522 Dose Level F	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 2: Placebo Standard Meal	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cohort 2: PF-06954522 Dose Level B	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal)	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Cohort 2: PF-06954522 Dose Level F	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Cohort 3: Placebo	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Cohort 3: Placebo (Fed)	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 3: PF-06954522 Dose Level D	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal)	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Cohort 3: PF-06954522 Dose Level E	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Limitations and caveats (from the sponsor): Any untoward findings identified on physical examination and/or cardiac telemetry conducted during the active collection period were captured as adverse events, if those findings met the definition of an AE.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.

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-06954522 in people with Healthy Participants, run by Pfizer at 1 site in United States.

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 2 inclusion and 12 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: finished, as of the sponsor's last update on 24 Jun 2025. 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 United States. 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?

Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06003777.

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 24 Jun 2025.