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

NCT06003777 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C4001001NCT06003777
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (18)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

• Cohort 2: AUClast of PF-06954522

  From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

• Cohort 1: Maximum Observed Concentration (Cmax) of PF-06954522

  From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

• Cohort 2: Cmax of PF-06954522

  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

  From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Study Arms (3)

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.

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.

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.

Drug: PF-06954522; Drug: Placebo

Interventions

PF-06954522 DRUG

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

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Placebo will be administered as oral suspensions as escalating single doses to be determined.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

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).
• 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:
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin
• × 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Limitations and Caveats

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.

Results Point of Contact

• Title: Name or Official Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 22, 2023
• Study Start: August 30, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)