HealthyPhase 1NCT05654181

A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants

A Phase 1 study testing PF-07328948 in people with Healthy, 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

This study is the first clinical study with PF-07328948. The safety, tolerability, and plasma pharmacokinetics and pharmacodynamics of PF-07328948 after administration of escalating, single, oral doses will be evaluated. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PF-07328948
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 17 Oct 2022to 3 May 2023
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Female participants of non-childbearing potential and males must be 18 to 60 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
Female participants of non-childbearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

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).
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, or HCVAb. Hepatitis B vaccination is allowed.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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.
Receipt of a COVID-19 vaccine within 7 days before screening or within 7 days before any visit in which a safety lab is planned. Vaccination with a COVID 19 vaccine that occurs greater than 7 days from either screening or any visit in which a safety lab is planned is permitted.

Show all 15Show fewer

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).
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
Renal impairment as defined by an eGFR <75 mL/min/1.73m2 calculated using CKD EPI SCr formulas.
Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate age myocardial infarction, STT interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is >450 ms, this interval should be rate corrected using the Fridericia method only and the resulting QTcF should be used for decision-making and reporting.
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:
AST or ALT level ≥1.25× ULN;
Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ULN.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Trial locations and contacts

1 site in 1 country.

United States1 site

New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF PF-07328948 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS

Conditions: Healthy
Being tested: PF-07328948, Placebo

What participants receive

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

PF-07328948Drug
investigational drug administered orally
PlaceboDrug
Placebo matching active drug administered orally

Study groups in NCT05654181
Study group	Role	What they receive
Cohort 1	Experimental	Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined. Receives: Drug: PF-07328948; Drug: Placebo
Cohort 2	Experimental	Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined. Receives: Drug: PF-07328948; Drug: Placebo
Cohort 3	Experimental	Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined. Receives: Drug: PF-07328948; Drug: Placebo

What is being measured

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

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality
Pre-defined categorical criteria for laboratory abnormalities included: lymphocytes/Leukocytes <0.8 x lower limit of normal (LLN) or >1.2 x upper limit of normal (ULN); Neutrophils <0.8 x LLN; Neutrophils/Leukocytes <0.8 x LLN; Eosinophils/Leukocytes >1.2 x ULN; Monocytes/Leukocytes >1.2 x ULN; Bilirubin >1.5 x ULN; Indirect Bilirubin >1.5 x ULN; Ketones (Scalar) ≥1; URINE Hemoglobin (Scalar) ≥1; URINE Bilirubin (Scalar) ≥1; Leukocyte Esterase (Scalar) ≥1; and Bacteria (/HPF) >20.
Measured: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.
Measured: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is > 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec.
1. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline.
2. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and ≤480 msec, b) >480 msec and ≤500 msec, c) >500 msec, d) >30 msec and ≤60 msec increase from baseline, e) >60 msec increase from baseline
Measured: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Change From Baseline in Electrocardiogram (ECG) Parameters (ECG Mean Heart Rate)
Maximum increase from baseline in ECG Mean Heart Rate was reported.
Measured: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Change From Baseline in ECG Parameters (PR Interval, QRS Duration, and QTcF Interval)
Maximum increase from baseline in PR Interval, QRS Duration, and QTcF Interval was reported.
Measured: Day 1-8 per period, along with the 28-35 day post-final dose follow-up

Secondary outcomes (5)

Maximum Concentration Observed in Plasma (Cmax)
Maximum observed plasma PF-07328948 concentration. Observed directly from data.
Measured: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)
Time to Achieve Cmax (Tmax)
Observed directly from data as time of first occurrence.
Measured: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration. It was determined by using linear/Log trapezoidal method.
Measured: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)
Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time. AUCinf = AUClast + (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis, and Kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, AUClast = Area under the plasma concentration time-curve from zero to the last measured concentration.
Measured: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)
Terminal Half-Life (t1/2) of PF-07328948
Terminal elimination half-life. t1/2 = Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log linear decline will be used in the regression.
Measured: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)

Timeline

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

17 Oct 20223 May 2023

First posted16 Dec 2022
Study start17 Oct 2022
Primary completion3 May 2023
Study completion3 May 2023

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 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05654181
Sponsor's protocol ID: C4921001
Status last verified: Nov 2024
First submitted: 13 Oct 2022
Last updated: 5 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
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?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2024. 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, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF PF-07328948 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT05654181
Acronym / sponsor ID: C4921001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 17 Oct 2022 (actual)
Primary completion: 3 May 2023 (actual)
Study completion: 3 May 2023 (actual)
First posted: 16 Dec 2022 (actual)
Results: Posted 5 Nov 2024

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Cohort 1	Experimental	Drug: PF-07328948, Drug: PlaceboParticipants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined.
Cohort 2	Experimental	Drug: PF-07328948, Drug: PlaceboParticipants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined.
Cohort 3	Experimental	Drug: PF-07328948, Drug: PlaceboParticipants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Female participants of non-childbearing potential and males must be 18 to 60 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
Female participants of non-childbearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Key exclusion criteria (15 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).
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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.
Receipt of a COVID-19 vaccine within 7 days before screening or within 7 days before any visit in which a safety lab is planned. Vaccination with a COVID 19 vaccine that occurs greater than 7 days from either screening or any visit in which a safety lab is planned is permitted.
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).

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-07328948investigational drug administered orally	Drug	Cohort 1, Cohort 2, Cohort 3
PlaceboPlacebo matching active drug administered orally	Drug	Cohort 1, Cohort 2, Cohort 3

Primary outcome

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality
Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Pre-defined categorical criteria for laboratory abnormalities included: lymphocytes/Leukocytes <0.8 x lower limit of normal (LLN) or >1.2 x upper limit of normal (ULN); Neutrophils <0.8 x LLN; Neutrophils/Leukocytes <0.8 x LLN; Eosinophils/Leukocytes >1.2 x ULN; Monocytes/Leukocytes >1.2 x ULN; Bilirubin >1.5 x ULN; Indirect Bilirubin >1.5 x ULN; Ketones (Scalar) ≥1; URINE Hemoglobin (Scalar) ≥1; URINE Bilirubin (Scalar) ≥1; Leukocyte Esterase (Scalar) ≥1; and Bacteria (/HPF) >20.
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is > 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and ≤480 msec, b) >480 msec and ≤500 msec, c) >500 msec, d) >30 msec and ≤60 msec increase from baseline, e) >60 msec increase from baseline
Change From Baseline in Electrocardiogram (ECG) Parameters (ECG Mean Heart Rate)
Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Maximum increase from baseline in ECG Mean Heart Rate was reported.
Change From Baseline in ECG Parameters (PR Interval, QRS Duration, and QTcF Interval)
Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Maximum increase from baseline in PR Interval, QRS Duration, and QTcF Interval was reported.

5 secondary outcomes

Maximum Concentration Observed in Plasma (Cmax)
Time frame: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)
Time to Achieve Cmax (Tmax)
Time frame: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast)
Time frame: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)
Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)
Terminal Half-Life (t1/2) of PF-07328948
Time frame: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)

Results and safety

Results posted to the registry on 5 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-07328948 10 mg, PF-07328948 30 mg, PF-07328948 100 mg, Placebo	3	2
PF-07328948 10 mg, PF-07328948 30 mg, Placebo, PF-07328948 300 mg	2	2
PF-07328948 10 mg, Placebo, PF-07328948 100 mg, PF-07328948 300 mg	2	2
Placebo, PF-07328948 30 mg, PF-07328948 100 mg, PF-07328948 300 mg	2	2
PF-07328948 750 mg, PF-07328948 F mg, PF-07328948 G mg, Placebo	1	0
Placebo, PF-07328948 F mg, PF-07328948 G mg, PF-07328948 H mg	1	0
PF-07328948 300 mg, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed)	2	2
PF-07328948 300 mg, PF-07328948 750 mg, Placebo, PF-07328948 750 mg (Fed)	3	1
PF-07328948 300 mg, Placebo, PF-07328948 1500 mg, Placebo (Fed)	2	2
Placebo, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed)	2	2

Primary outcome: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)

Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up. Count of participants. Unit: Participants

Measure	Placebo n = 13	Placebo (Fed) n = 2	PF-07328948 10 mg n = 6	PF-07328948 30 mg n = 5	PF-07328948 100 mg n = 5	PF-07328948 300 mg n = 12	PF-07328948 750 mg n = 7	PF-07328948 750 mg (Fed) n = 5	PF-07328948 1500 mg n = 6
All-causality AEs	3	1	3	2	1	5	3	1	2
Treatment-related AEs	1	0	0	0	0	4	2	0	1
All-causality SAEs	1	0	0	0	0	0	0	0	0
Treatment-related SAEs	1	0	0	0	0	0	0	0	0

Population analysed: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Primary outcome: Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality

Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up. Count of participants. Unit: Participants

Measure	Placebo n = 13	Placebo (Fed) n = 2	PF-07328948 10 mg n = 6	PF-07328948 30 mg n = 5	PF-07328948 100 mg n = 5	PF-07328948 300 mg n = 12	PF-07328948 750 mg n = 7	PF-07328948 750 mg (Fed) n = 5	PF-07328948 1500 mg n = 6
Value	0	0	1	2	1	3	3	1	2

Primary outcome: Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria

Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up. Count of participants. Unit: Participants

Measure	Placebo n = 13	PF-07328948 300 mg n = 12	PF-07328948 750 mg n = 7
SBP <90 mmHg	0	0	1
Change from baseline in SBP ≥30 mmHg decrease	0	0	0
Change from baseline in SBP ≥30 mmHg increase	0	1	0
DBP <50 mmHg	0	0	0
Change from baseline in DBP ≥20 decrease	0	0	0
Change from baseline in DBP ≥20 increase	1	1	0
Pulse rate < 40 bpm	0	0	0
Pulse rate > 120 bpm	0	1	0

Primary outcome: Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria

Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up. Count of participants. Unit: Participants

Measure	Placebo n = 13	Placebo (Fed) n = 2	PF-07328948 10 mg n = 6	PF-07328948 30 mg n = 5	PF-07328948 100 mg n = 5	PF-07328948 300 mg n = 12	PF-07328948 750 mg n = 7	PF-07328948 750 mg (Fed) n = 5	PF-07328948 1500 mg n = 6
PR interval ≥300 msec	0	0	0	0	0	0	0	0	0
%Change in PR interval ≥25/50% increase	0	0	0	0	0	0	0	0	0
QRS interval ≥140 msec	0	0	0	0	0	0	0	0	0
%Change in QRS interval ≥50% increase	0	0	0	0	0	0	0	0	0
QTcF interval >450 and ≤480 msec	0	0	0	0	0	0	0	0	0
QTcF interval >480 and ≤500 msec	0	0	0	0	0	0	0	0	0
QTcF interval >500 msec	0	0	0	0	0	0	0	0	0
Change in QTcF interval >30 and ≤60 msec	0	0	0	0	0	0	0	0	0

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 13 (7.7%)	3 of 13 (23.1%)	0 of 13
Placebo (Fed)	0 of 2 (0%)	1 of 2 (50%)	0 of 2
PF-07328948 10 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
PF-07328948 30 mg	0 of 5 (0%)	2 of 5 (40%)	0 of 5
PF-07328948 100 mg	0 of 5 (0%)	1 of 5 (20%)	0 of 5
PF-07328948 300 mg	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
PF-07328948 750 mg	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7
PF-07328948 750 mg (Fed)	0 of 5 (0%)	1 of 5 (20%)	0 of 5
PF-07328948 1500 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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-07328948 in people with Healthy, 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 3 inclusion and 15 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 5 Nov 2024. 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 5 Nov 2024). 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?

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) (time frame: Day 1-8 per period, along with the 28-35 day post-final dose follow-up). The study lists 6 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 NCT05654181.

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 5 Nov 2024.