Healthy ParticipantsPhase 1NCT05907395

A Study to Learn About the Study Medicine (PF-07293893) at Different Dose Levels in Healthy Adults

A Phase 1 study testing PF-07293893 in people with Healthy Participants, run by Pfizer at 1 site in Belgium.

Completed

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

Trial summary

The purposes of the study are: To learn about the safety and tolerability of study medicine (PF-07293893). Tolerability is the extent to which side effects can be tolerated. Side effects are unwanted reactions to the study medicine. To measure the amount of PF-07293893 in blood after the medicine is taken 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-07293893
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteBelgium
Study dates: 9 Aug 2023to 22 Mar 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

This study is seeking participants who are:

Females of non-childbearing potential and males 18 to 65 years of age, inclusive, at the time of signing the informed consent document (ICD) who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

This study is not seeking participants who have:

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).
History of human immunodeficiency virus infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen, or hepatitis C antibody. Hepatitis B vaccination is allowed.
Any 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 coronavirus disease 2019 (COVID-19) pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the 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) <75 mL/min/1.73m².
Standard 12-lead electrocardiogram (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), total bilirubin ≥1.05 × upper limit of normal (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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

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, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07293893 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS

The purposes of the study are:

To learn about the safety and tolerability of study medicine (PF-07293893). Tolerability is the extent to which side effects can be tolerated. Side effects are unwanted reactions to the study medicine.

To measure the amount of PF-07293893 in blood after the medicine is taken by mouth.

The study is seeking participants who:

Are females of non-childbearing potential and males 18 to 65 years of age
Are in generally healthy condition
Have not had viral infections (HIV, HBV or HCV). HIV, human immunodeficiency virus. HBV, human hepatitis B virus. HCV, human hepatitis C virus.

Participants will receive either PF-07293893 or placebo (dummy pill) by chance. Participants will undergo up to 4 treatments periods in this study. Everyone will receive up to 4 doses of study medicine and up to 2 doses of placebo. In each period, participants will stay in study clinic for 5 days. There will be at least 2 days between each treatment period.

Participants will be involved in this study for about 14 weeks. During their stay, participants will undergo several examinations. Participants will also have their blood collected by the study doctors for several times.

Conditions: Healthy Participants
Being tested: PF-07293893, Placebo
Keywords: PF-07293893, Single ascending dose, Safety, Tolerability, Pharmacokinetics

What participants receive

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

PF-07293893Drug
PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.
PlaceboDrug
Matching placebo will be prepared as an oral suspension given in each cohort.

Study groups in NCT05907395
Study group	Role	What they receive
PF-07293893 and Placebo (Cohort 1)	Experimental	Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo. Receives: Drug: PF-07293893; Drug: Placebo
PF-07293893 and Placebo (Cohort 2)	Experimental	Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo. Receives: Drug: PF-07293893; Drug: Placebo
PF-07293893 and Placebo (Cohort 3)	Experimental	Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo. Receives: Drug: PF-07293893; Drug: Placebo

What is being measured

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

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug.
Measured: Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
Number of Participants With Laboratory Test Abnormalities
Following parameters were analyzed for laboratory abnormalities: hematology (lymphocytes <0.8*lower limit of normal [LLN], lymphocytes/leukocytes <0.8*LLN, neutrophils <0.8*LLN, neutrophils/leukocytes <0.8*LLN, eosinophils/leukocytes >1.2*upper limit of normal [ULN], monocytes >1.2*ULN, monocytes/leukocytes >1.2*ULN); clinical chemistry (aspartate aminotransferase >3.0*ULN, potassium >1.1*ULN, creatine kinase >2.0*ULN); urinalysis (urine specific gravity <1.003 ,>1.030, ketones >=1, urine hemoglobin >=1, urobilinogen >=1, urine bilirubin >=1, leukocyte esterase >=1). In this outcome measure, participants with any laboratory abnormalities are reported.
Measured: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs assessments included blood pressure, pulse rate, respiratory rate and body temperature. Clinical significance of vital signs was determined based by investigator's discretion.
Measured: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
ECG parameters included heart rate, PR interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. Clinically significant ECG findings were determined by the investigator's discretion.
Measured: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)

Secondary outcomes (5)

Maximum Plasma Concentration (Cmax) of PF-07293893
Measured: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Time for Cmax (Tmax) of PF-07293893
Measured: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07293893
AUClast was calculated using linear/log trapezoidal method.
Measured: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Area Under the Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07293893
AUCinf was calculated as AUClast + (Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
Measured: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Terminal Half-Life (t1/2) of PF-07293893
t1/2 was calculated as log^e (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Measured: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period

Timeline

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

9 Aug 202322 Mar 2024

First posted18 Jun 2023
Study start9 Aug 2023
Primary completion22 Mar 2024
Study completion22 Mar 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05907395
Sponsor's protocol ID: C5171001
Other IDs: 2023-504921-37-00, 2023
Status last verified: Mar 2025
First submitted: 8 Jun 2023
Last updated: 10 Apr 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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 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, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07293893 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT05907395
Acronym / sponsor ID: C5171001
Conditions: Healthy Participants
Keywords: PF-07293893, Single ascending dose, Safety, Tolerability, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 9 Aug 2023 (actual)
Primary completion: 22 Mar 2024 (actual)
Study completion: 22 Mar 2024 (actual)
First posted: 18 Jun 2023 (actual)
Results: Posted 10 Apr 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 the study are:

To measure the amount of PF-07293893 in blood after the medicine is taken by mouth.

The study is seeking participants who:

Are females of non-childbearing potential and males 18 to 65 years of age
Are in generally healthy condition
Have not had viral infections (HIV, HBV or HCV). HIV, human immunodeficiency virus. HBV, human hepatitis B virus. HCV, human hepatitis C virus.

Study design

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

Arm	Type	Receives
PF-07293893 and Placebo (Cohort 1)	Experimental	Drug: PF-07293893, Drug: PlaceboSingle dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.
PF-07293893 and Placebo (Cohort 2)	Experimental	Drug: PF-07293893, Drug: PlaceboSingle dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.
PF-07293893 and Placebo (Cohort 3)	Experimental	Drug: PF-07293893, Drug: PlaceboSingle dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.

Who may qualify

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

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-07293893PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.	Drug	PF-07293893 and Placebo (Cohort 1), PF-07293893 and Placebo (Cohort 2), PF-07293893 and Placebo (Cohort 3)
PlaceboMatching placebo will be prepared as an oral suspension given in each cohort.	Drug	PF-07293893 and Placebo (Cohort 1), PF-07293893 and Placebo (Cohort 2), PF-07293893 and Placebo (Cohort 3)

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug.
Number of Participants With Laboratory Test Abnormalities
Time frame: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Following parameters were analyzed for laboratory abnormalities: hematology (lymphocytes <0.8*lower limit of normal [LLN], lymphocytes/leukocytes <0.8*LLN, neutrophils <0.8*LLN, neutrophils/leukocytes <0.8*LLN, eosinophils/leukocytes >1.2*upper limit of normal [ULN], monocytes >1.2*ULN, monocytes/leukocytes >1.2*ULN); clinical chemistry (aspartate aminotransferase >3.0*ULN, potassium >1.1*ULN, creatine kinase >2.0*ULN); urinalysis (urine specific gravity <1.003 ,>1.030, ketones >=1, urine hemoglobin >=1, urobilinogen >=1, urine bilirubin >=1, leukocyte esterase >=1). In this outcome measure, participants with any laboratory abnormalities are reported.
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Vital signs assessments included blood pressure, pulse rate, respiratory rate and body temperature. Clinical significance of vital signs was determined based by investigator's discretion.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
ECG parameters included heart rate, PR interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. Clinically significant ECG findings were determined by the investigator's discretion.

5 secondary outcomes

Maximum Plasma Concentration (Cmax) of PF-07293893
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Time for Cmax (Tmax) of PF-07293893
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07293893
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Area Under the Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07293893
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Terminal Half-Life (t1/2) of PF-07293893
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period

Results and safety

Results posted to the registry on 10 Apr 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	2	1
Cohort 1: Sequence 3	2	2
Cohort 1: Sequence 4	2	2
Cohort 2: Sequence 1	2	2
Cohort 2: Sequence 2	2	1
Cohort 2: Sequence 3	2	1
Cohort 2: Sequence 4	2	2
Cohort 3: Sequence 1	2	2
Cohort 3: Sequence 2	2	2
Cohort 3: Sequence 3	2	2
Cohort 3: Sequence 4	2	2

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

Time frame: Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days). Count of participants. Unit: Participants

Measure	PF-07293893 10 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 30 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 100 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 300 mg: CRYS/Fasted Cohort 2 n = 6	PF-07293893 300 mg: CRYS/Fed Cohort 2 n = 5	PF-07293893 300 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 750 mg: SDD/Fasted Cohort 2 n = 6	PF-07293893 750 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3 n = 12	PF-07293893 750 mg: SDD/Fed Cohort 3 n = 6	PF-07293893 900 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 1200 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 1500 mg: SDD/Fasted Cohort 2 n = 6	Placebo: CRYS/Fasted Cohort 2 n = 2	Placebo: CRYS/Fed Cohort 2 n = 2	Placebo: SDD/Fasted Combined for All Cohorts n = 18	Placebo: SDD/Fed Cohort 2 n = 2
Value	1	2	1	2	3	3	3	5	8	2	4	3	4	2	1	6	1

Population analysed: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Primary outcome: Number of Participants With Laboratory Test Abnormalities

Time frame: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days). Count of participants. Unit: Participants

Measure	PF-07293893 10 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 30 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 100 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 300 mg: CRYS/Fasted Cohort 2 n = 6	PF-07293893 300 mg: CRYS/Fed Cohort 2 n = 5	PF-07293893 300 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 750 mg: SDD/Fasted Cohort 2 n = 6	PF-07293893 750 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3 n = 12	PF-07293893 750 mg: SDD/Fed Cohort 3 n = 6	PF-07293893 900 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 1200 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 1500 mg: SDD/Fasted Cohort 2 n = 6	Placebo: CRYS/Fasted Cohort 2 n = 2	Placebo: CRYS/Fed Cohort 2 n = 2	Placebo: SDD/Fasted Combined for All Cohorts n = 18	Placebo: SDD/Fed Cohort 2 n = 2
Value	3	3	4	2	2	2	1	2	3	4	4	3	3	2	1	7	1

Primary outcome: Number of Participants With Clinically Significant Changes in Vital Signs

Time frame: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days). Count of participants. Unit: Participants

Measure	PF-07293893 10 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 30 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 100 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 300 mg: CRYS/Fasted Cohort 2 n = 6	PF-07293893 300 mg: CRYS/Fed Cohort 2 n = 5	PF-07293893 300 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 750 mg: SDD/Fasted Cohort 2 n = 6	PF-07293893 750 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3 n = 12	PF-07293893 750 mg: SDD/Fed Cohort 3 n = 6	PF-07293893 900 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 1200 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 1500 mg: SDD/Fasted Cohort 2 n = 6	Placebo: CRYS/Fasted Cohort 2 n = 2	Placebo: CRYS/Fed Cohort 2 n = 2	Placebo: SDD/Fasted Combined for All Cohorts n = 18	Placebo: SDD/Fed Cohort 2 n = 2
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Primary outcome: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

Time frame: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days). Count of participants. Unit: Participants

Measure	PF-07293893 10 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 30 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 100 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 300 mg: CRYS/Fasted Cohort 2 n = 6	PF-07293893 300 mg: CRYS/Fed Cohort 2 n = 5	PF-07293893 300 mg: SDD/Fasted Cohort 1 n = 6	PF-07293893 750 mg: SDD/Fasted Cohort 2 n = 6	PF-07293893 750 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3 n = 12	PF-07293893 750 mg: SDD/Fed Cohort 3 n = 6	PF-07293893 900 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 1200 mg: SDD/Fasted Cohort 3 n = 6	PF-07293893 1500 mg: SDD/Fasted Cohort 2 n = 6	Placebo: CRYS/Fasted Cohort 2 n = 2	Placebo: CRYS/Fed Cohort 2 n = 2	Placebo: SDD/Fasted Combined for All Cohorts n = 18	Placebo: SDD/Fed Cohort 2 n = 2
Value	0	0	0	0	0	0	0	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 of first dose up to maximum of 35 days post last dose (up to 60 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-07293893 10 mg: SDD/Fasted Cohort 1	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
PF-07293893 30 mg: SDD/Fasted Cohort 1	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
PF-07293893 100 mg: SDD/Fasted Cohort 1	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
PF-07293893 300 mg: CRYS/Fasted Cohort 2	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
PF-07293893 300 mg: CRYS/Fed Cohort 2	0 of 5 (0%)	3 of 5 (60%)	0 of 5
PF-07293893 300 mg: SDD/Fasted Cohort 1	0 of 6 (0%)	3 of 6 (50%)	0 of 6
PF-07293893 750 mg: SDD/Fasted Cohort 2	0 of 6 (0%)	3 of 6 (50%)	0 of 6
PF-07293893 750 mg: SDD/Fasted Cohort 3	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12
PF-07293893 750 mg: SDD/Fed Cohort 3	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
PF-07293893 900 mg: SDD/Fasted Cohort 3	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
PF-07293893 1200 mg: SDD/Fasted Cohort 3	0 of 6 (0%)	3 of 6 (50%)	0 of 6
PF-07293893 1500 mg: SDD/Fasted Cohort 2	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Placebo: CRYS/Fasted Cohort 2	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Placebo: CRYS/Fed Cohort 2	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Placebo: SDD/Fasted Combined for All Cohorts	0 of 18 (0%)	6 of 18 (33.3%)	0 of 18
Placebo: SDD/Fed Cohort 2	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Limitations and caveats (from the sponsor): Any untoward findings identified on physical and/or neurological examinations, 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 10 Apr 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-07293893 in people with Healthy Participants, run by Pfizer at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 10 Apr 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 Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 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 With Treatment Emergent Adverse Events (TEAEs) (time frame: Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)). 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 NCT05907395.

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 10 Apr 2025.