Healthy ParticipantsPhase 1NCT05890105

A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults

A Phase 1 study testing PF-07853578 in people with Healthy Participants, run by Pfizer at 2 sites 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-07853578) under study is tolerated. And if there are any important side effects. And, how people feel after taking single increasing amount of the medicine by mouth. 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-07853578
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 2 sitesUnited States
Study dates: 2 Jun 2023to 1 Dec 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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female participants of non-childbearing potential and male participants aged 18 to 65 years 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.
Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest.
Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73m².
Hematuria as defined by >1+ heme on urine dipstick.

Show all 11Show fewer

Albuminuria as defined by albumin/creatine (Cr) ratio on spot urine albumin (UA) >30 mg/g.
Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
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), Bilirubin ≥1.05×ULN.
Total cholesterol, triglycerides, or direct LDL ≥1.25×ULN.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

New Haven Clinical Research Unit
New Haven, Connecticut, 06511
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 Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of PF-07853578 Administered to Healthy Adult Participants

The purposes of this study are:

To see how the new medicine (PF-07853578) under study is tolerated. And if there are any important side effects. And, 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 randomly selected to receive either study medicine (PF-07853578) 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.

Conditions: Healthy Participants
Being tested: PF-07853578, Placebo

What participants receive

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

PF-07853578Drug
PF-07853578 will be administered as oral solutions or suspensions as escalating single doses to be determined.
PlaceboDrug
Placebo will be administered as oral solutions or suspensions as escalating single doses to be determined.

Study groups in NCT05890105
Study group	Role	What they receive
Cohort 1	Experimental	Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo. Receives: Drug: PF-07853578; Drug: Placebo
Cohort 2	Experimental	Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo. Receives: Drug: PF-07853578; Drug: Placebo
Cohort 3	Experimental	Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo. Receives: Drug: PF-07853578; 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 1-11 in each period, along with the 29-36 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 <0.8 x lower limit of normal (LLN); Basophils/Leukocytes > 1.2 x upper limit of normal (ULN); Eosinophils/Leukocytes >1.2 x ULN; Monocytes/Leukocytes >1.2 x ULN; low-density lipoprotein (LDL) Direct Endpoint Measure >1.2 x ULN; Triglycerides >1.3 x ULN; Specific Gravity <1.003 or >1.030; pH >8; Ketones ≥1; Urobilinogen (EU) ≥1; URINE Bilirubin ≥1; Leukocyte Esterase ≥1.
Measured: Day 1-11 in each period, along with the 29-36 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 1-11 in each period, along with the 29-36 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, c) ≥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 1-11 in each period, along with the 29-36 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 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)
Time to Achieve Cmax (Tmax)
Observed directly from data as time of first occurrence.
Measured: Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment 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 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment 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* was 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 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)
Terminal Half-Life (t1/2)
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 were used in the regression.
Measured: Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment 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.

2 Jun 20231 Dec 2023

First posted6 Jun 2023
Study start2 Jun 2023
Primary completion1 Dec 2023
Study completion1 Dec 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 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05890105
Sponsor's protocol ID: C5161001
Status last verified: Nov 2024
First submitted: 25 May 2023
Last updated: 3 Jan 2025
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 3 Jan 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 Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of PF-07853578 Administered to Healthy Adult Participants
ClinicalTrials.gov ID: NCT05890105
Acronym / sponsor ID: C5161001
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 2 Jun 2023 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 6 Jun 2023 (actual)
Results: Posted 3 Jan 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-07853578) under study is tolerated. And if there are any important side effects. And, 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 randomly selected to receive either study medicine (PF-07853578) 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.

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-07853578, Drug: PlaceboSingle dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.
Cohort 2	Experimental	Drug: PF-07853578, Drug: PlaceboSingle dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.
Cohort 3	Experimental	Drug: PF-07853578, Drug: PlaceboSingle dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels 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)

Female participants of non-childbearing potential and male participants aged 18 to 65 years 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 (11 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.
Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest.
Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73m².

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-07853578PF-07853578 will be administered as oral solutions or suspensions as escalating single doses to be determined.	Drug	Cohort 1, Cohort 2, Cohort 3
PlaceboPlacebo will be administered as oral solutions or suspensions as escalating single doses to be determined.	Drug	Cohort 1, Cohort 2, Cohort 3

Primary outcome

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1-11 in each period, along with the 29-36 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 1-11 in each period, along with the 29-36 day post final dose follow-up
Pre-defined categorical criteria for laboratory abnormalities included: Lymphocytes <0.8 x lower limit of normal (LLN); Basophils/Leukocytes > 1.2 x upper limit of normal (ULN); Eosinophils/Leukocytes >1.2 x ULN; Monocytes/Leukocytes >1.2 x ULN; low-density lipoprotein (LDL) Direct Endpoint Measure >1.2 x ULN; Triglycerides >1.3 x ULN; Specific Gravity <1.003 or >1.030; pH >8; Ketones ≥1; Urobilinogen (EU) ≥1; URINE Bilirubin ≥1; Leukocyte Esterase ≥1.
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Time frame: Day 1-11 in each period, along with the 29-36 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 1-11 in each period, along with the 29-36 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, c) ≥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.

5 secondary outcomes

Maximum Concentration Observed in Plasma (Cmax)
Time frame: Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)
Time to Achieve Cmax (Tmax)
Time frame: Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment 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 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)
Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)
Terminal Half-Life (t1/2)
Time frame: Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)

Results and safety

Results posted to the registry on 3 Jan 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	8	6
Cohort 2	8	6
Cohort 3	7	7

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

Time frame: Day 1-11 in each period, along with the 29-36 day post final dose follow-up. Count of participants. Unit: Participants

Measure	PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution) n = 5	3 mg n = 6	8 mg n = 5	8 mg (Intermediate Dosage Strength [IDS] Solution) n = 5	10 mg n = 5	30 mg n = 6	300 mg n = 6	300 mg Fed n = 5	Placebo Fasted n = 14
All-causality AEs	1	2	3	2	2	1	1	4	3
Treatment-related AEs	0	0	1	0	2	0	0	0	1
All-causality SAEs	0	0	0	0	0	0	0	0	0
Treatment-related SAEs	0	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 1-11 in each period, along with the 29-36 day post final dose follow-up. Count of participants. Unit: Participants

Measure	PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution) n = 5	3 mg n = 6	8 mg n = 5	8 mg (Intermediate Dosage Strength [IDS] Solution) n = 5	10 mg n = 5	30 mg n = 6	100 mg n = 5	300 mg n = 6	300 mg Fed n = 5	500 mg n = 4	Placebo Fasted n = 14	Placebo Fed n = 1
Value	4	5	5	4	5	5	4	4	2	1	11	1

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

Time frame: Day 1-11 in each period, along with the 29-36 day post final dose follow-up. Count of participants. Unit: Participants

Measure	PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution) n = 5	3 mg n = 6	8 mg n = 5	8 mg (Intermediate Dosage Strength [IDS] Solution) n = 5	10 mg n = 5	30 mg n = 6	100 mg n = 5	300 mg n = 6	300 mg Fed n = 5	500 mg n = 4	Placebo Fasted n = 14	Placebo Fed n = 1
DBP <50 mmHg	0	0	0	0	0	0	0	0	1	0	0	0
Pulse rate < 40 bpm	0	1	0	0	0	1	0	0	0	0	0	0
Pulse rate > 120 bpm	0	0	0	0	0	0	0	0	0	0	0	0
SBP <90 mmHg	0	0	1	0	0	0	0	2	1	0	0	0
Change from baseline in DBP ≥20 increase	0	0	0	0	0	0	0	0	0	0	0	0
Change from baseline in DBP ≥20 decrease	0	0	0	0	0	0	0	0	0	0	1	0
Change from baseline in SBP ≥30 mmHg increase

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

Time frame: Day 1-11 in each period, along with the 29-36 day post final dose follow-up. Count of participants. Unit: Participants

Measure	PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution) n = 5	3 mg n = 6	8 mg n = 5	8 mg (Intermediate Dosage Strength [IDS] Solution) n = 5	10 mg n = 5	30 mg n = 6	100 mg n = 5	300 mg n = 6	300 mg Fed n = 5	500 mg n = 4	Placebo Fasted n = 14	Placebo Fed n = 1
Value	0	1	0	0	0	0	0	0	0	0	0	0

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1-11 in each period, along with the 29-36 day post final dose follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)	0 of 5 (0%)	1 of 5 (20%)	0 of 5
3 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
8 mg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
8 mg (Intermediate Dosage Strength [IDS] Solution)	0 of 5 (0%)	2 of 5 (40%)	0 of 5
10 mg	0 of 5 (0%)	2 of 5 (40%)	0 of 5
30 mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
100 mg	0 of 5 (0%)	0 of 5 (0%)	0 of 5
300 mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
300 mg Fed	0 of 5 (0%)	4 of 5 (80%)	0 of 5
500 mg	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Placebo Fasted	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14
Placebo Fed	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): Any untoward findings identified on physical and/or neurological examinations, and cardiac monitoring 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 3 Jan 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

2 sites 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-07853578 in people with Healthy Participants, run by Pfizer at 2 sites 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 11 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 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 Jan 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?

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) (time frame: Day 1-11 in each period, along with the 29-36 day post final dose follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05890105.

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 3 Jan 2025.