HealthyPhase 1NCT04863417

Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants

A Phase 1 study of Healthy, run by Pfizer at 1 site in Japan.

Completed

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

Trial summary

The purpose of this study is to evaluate the safety, tolerability, skin irritation potential, and PK of PF-07038124 in Japanese healthy adult participants. Read more about this study

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteJapan
Study dates: 30 Jun 2021to 9 Sep 2021
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 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the ICD.
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Participants must have 4 biologically Japanese grandparents who were born in Japan.
BMI of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

Participants who have any visible skin damage or skin condition (eg, sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations) in or around the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
Participants who have a history of or have active forms of dermatitides/eczematous conditions (eg, contact dermatitis, seborrhhoeic, discoid, gravitational, asteatotic and dishydrotic eczema) or other inflammatory skin diseases(eg, psoriasis, viral infection, fungal infection, bacterial infection) that would interfere with evaluation of the test site reaction.
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 HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, HCVAb, or syphilis at screening. Hepatitis B vaccination is allowed.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Acute disease state (unstable medical condition such as nausea, vomiting, fever or diarrhea, etc) within 7 days of Day 1.

Show all 23Show fewer

Have undergone significant trauma or major surgery within 4 weeks of screening.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Previous administration with an investigational drug within 4 months (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).
A positive urine drug test at screening and/or Day -1.
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmia's or tachyarrhythmias).
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 ≥1.5 × 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.
A positive COVID-19 test at screening.
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).
Blood donation (excluding plasma donations) of approximately ≥400 mL within 3 months or ≥200 mL within a month prior to dosing. Additionally, approximately ≥400 mL within 4 months for female participants.
History of serious adverse reactions or hypersensitivity to any topical drug; or known allergy to any of the study intervention or any components in the study intervention or history of hypersensitivity; or allergic reactions to any of the study preparations.
Not willing to refrain from shaving (Note: shaving around face is permitted), the use of depilatories or other hair-removal activities, antiperspirants, lotions, skin creams, fragrances or perfumes, or body oils (eg, baby oil; coconut oil), use of hair products, hair gels, and hair oil in the treatment areas for 48 hours prior to admission to the CRU and for the duration of the stay in the CRU.
History of sensitivity to heparin or heparin induced thrombocytopenia only if heparin is planned to flush intravenous catheters.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Trial locations and contacts

1 site in 1 country.

Japan1 site

P-one clinic, Keikokai medical corporation
Hachiōji, Tokyo, 192-0071

Other trials in Japan

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL COHORT STUDY TO EVALUATE THE SAFETY, TOLERABILITY, SKIN IRRITATION POTENTIAL AND PHARMACOKINETICS OF MULTIPLE-DOSE, TOPICAL ADMINISTRATION OF PF-07038124 TO JAPANESE HEALTHY PARTICIPANTS

The purpose of this study is to evaluate the safety, tolerability, skin irritation potential, and PK of PF-07038124 in Japanese healthy adult participants.

Conditions: Healthy
Being tested: PF-07038124 or vehicle

What participants receive

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

PF-07038124 or vehicleDrug
PF-07038124 0.01% or vehicle Ointment QD applied to 2000 cm2 Body Surface Area
PF-07038124 or vehicleDrug
PF-07038124 0.01% or vehicle Ointment QD applied to 4000 cm2 Body Surface Area

Study groups in NCT04863417
Study group	Role	What they receive
Cohort 1 (2000 cm2 Body Surface Area)	Experimental	Not described Receives: Drug: PF-07038124 or vehicle
Cohort 2 (4000 cm2 Body Surface Area)	Experimental	Not described Receives: Drug: PF-07038124 or vehicle

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) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, not necessarily considered related to the study intervention. SAEs were defined as any AE which occurred at any dose and resulted in any of following outcomes: death, life-threatening experience (risk of death at the time of event), required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly. TEAEs are events between first dose of study drug up to maximum of 31 days after last dose of study drug.
Measured: Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)
Number of Participants With Clinically Significant Changes in Vital Signs During the Study
Vital signs that were assessed included supine systolic blood pressure, diastolic blood pressure and supine pulse rate. Clinical significance was determined based on investigator's discretion.
Measured: Day 1 up to Day 11
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study
ECG parameters that were assessed included PR interval, QRS interval, QT interval, QTCF (Fridericia's correction formula) and heart rate. Clinical significance was determined based on investigator's discretion.
Measured: Day 1 up to Day 11
Number of Participants With Clinically Significant Laboratory Abnormalities
Clinical laboratory tests included hematology, clinical chemistry and urinalysis parameters. Clinical significance of abnormalities in these parameters was determined based on investigator's discretion.
Measured: Day 1 up to Day 11
Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location
Draize score was used to measure the skin irritability based on erythema, edema, papules, and vesicles at the administration site. Draize score ranged from 0 to 4, where 0 indicated no reaction visible, 1 indicated trace reaction (barely perceptible pinkness), 2 indicated mild reaction (readily visible pinkness), 3 indicated moderate reaction (definite redness) and 4 indicated strong to severe reaction (very intense redness). In this outcome measure number of participants are reported according to their maximum score they had during the study through Day 1 to 11, regardless of visit and assessment location.
Measured: Through Day 1 to Day 11 (prior to application from Day 1-10 and 24 hours post application on Day 10)

Secondary outcomes (2)

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124
AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose). AUCtau only for PF-07038124 reporting groups is reported. Participants must have a minimum of 3 quantifiable concentrations to report AUC. All concentrations lesser than lower limit of quantification, then AUCtau=0.
Measured: 0 to 24 hours post dose on Day 1 and Day 10
Maximum Observed Plasma Concentration (Cmax) of PF-07038124
Cmax only for PF-07038124 reporting groups is reported.
Measured: Day 1 and 10: Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12, 24 hours post-dose

Timeline

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

30 Jun 20219 Sep 2021

First posted28 Apr 2021
Study start30 Jun 2021
Primary completion9 Sep 2021
Study completion9 Sep 2021

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.
Publications (1)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04863417
Sponsor's protocol ID: C3941003
Status last verified: Jan 2024
First submitted: 26 Apr 2021
Last updated: 25 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
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.

Publications

Ono R, Wada S, Matsuoka N, Tsunemi Y, Furihata K. Phase 1 Study of Topical Administration of Novel Phosphodiesterase-4 Inhibitor PF-07038124 in Japanese Healthy Participants. J Dermatol. 2025 Nov;52(11):1666-1673. doi: 10.1111/1346-8138.17914. Epub 2025 Aug 17.
PubMed 40820616

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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL COHORT STUDY TO EVALUATE THE SAFETY, TOLERABILITY, SKIN IRRITATION POTENTIAL AND PHARMACOKINETICS OF MULTIPLE-DOSE, TOPICAL ADMINISTRATION OF PF-07038124 TO JAPANESE HEALTHY PARTICIPANTS
ClinicalTrials.gov ID: NCT04863417
Acronym / sponsor ID: C3941003
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 30 Jun 2021 (actual)
Primary completion: 9 Sep 2021 (actual)
Study completion: 9 Sep 2021 (actual)
First posted: 28 Apr 2021 (actual)
Results: Posted 25 Jan 2024

Clinical summary

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

The purpose of this study is to evaluate the safety, tolerability, skin irritation potential, and PK of PF-07038124 in Japanese healthy adult participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cohort 1 (2000 cm2 Body Surface Area)	Experimental	Drug: PF-07038124 or vehicle
Cohort 2 (4000 cm2 Body Surface Area)	Experimental	Drug: PF-07038124 or vehicle

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the ICD.
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Participants must have 4 biologically Japanese grandparents who were born in Japan.
BMI of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).

Key exclusion criteria (23 listed)

Participants who have any visible skin damage or skin condition (eg, sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations) in or around the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
Participants who have a history of or have active forms of dermatitides/eczematous conditions (eg, contact dermatitis, seborrhhoeic, discoid, gravitational, asteatotic and dishydrotic eczema) or other inflammatory skin diseases(eg, psoriasis, viral infection, fungal infection, bacterial infection) that would interfere with evaluation of the test site reaction.
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 HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, HCVAb, or syphilis at screening. Hepatitis B vaccination is allowed.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

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-07038124 or vehiclePF-07038124 0.01% or vehicle Ointment QD applied to 2000 cm2 Body Surface Area	Drug	Cohort 1 (2000 cm2 Body Surface Area)
PF-07038124 or vehiclePF-07038124 0.01% or vehicle Ointment QD applied to 4000 cm2 Body Surface Area	Drug	Cohort 2 (4000 cm2 Body Surface Area)

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, not necessarily considered related to the study intervention. SAEs were defined as any AE which occurred at any dose and resulted in any of following outcomes: death, life-threatening experience (risk of death at the time of event), required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly. TEAEs are events between first dose of study drug up to maximum of 31 days after last dose of study drug.
Number of Participants With Clinically Significant Changes in Vital Signs During the Study
Time frame: Day 1 up to Day 11
Vital signs that were assessed included supine systolic blood pressure, diastolic blood pressure and supine pulse rate. Clinical significance was determined based on investigator's discretion.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study
Time frame: Day 1 up to Day 11
ECG parameters that were assessed included PR interval, QRS interval, QT interval, QTCF (Fridericia's correction formula) and heart rate. Clinical significance was determined based on investigator's discretion.
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Day 1 up to Day 11
Clinical laboratory tests included hematology, clinical chemistry and urinalysis parameters. Clinical significance of abnormalities in these parameters was determined based on investigator's discretion.
Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location
Time frame: Through Day 1 to Day 11 (prior to application from Day 1-10 and 24 hours post application on Day 10)
Draize score was used to measure the skin irritability based on erythema, edema, papules, and vesicles at the administration site. Draize score ranged from 0 to 4, where 0 indicated no reaction visible, 1 indicated trace reaction (barely perceptible pinkness), 2 indicated mild reaction (readily visible pinkness), 3 indicated moderate reaction (definite redness) and 4 indicated strong to severe reaction (very intense redness). In this outcome measure number of participants are reported according to their maximum score they had during the study through Day 1 to 11, regardless of visit and assessment location.

2 secondary outcomes

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124
Time frame: 0 to 24 hours post dose on Day 1 and Day 10
Maximum Observed Plasma Concentration (Cmax) of PF-07038124
Time frame: Day 1 and 10: Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12, 24 hours post-dose

Results and safety

Results posted to the registry on 25 Jan 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
Cohort 1: PF-07038124 2000 Centimeter Square (cm^2) Body Surface Area (BSA)	4	4
Cohort 1: Vehicle 2000 cm^2 BSA	2	2
Cohort 2: PF-07038124 4000 cm^2 BSA	4	4
Cohort 2: Vehicle 4000 cm^2 BSA	2	2

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

Time frame: Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days). Count of participants. Unit: Participants

Measure	Cohort 1: PF-07038124 2000 cm^2 BSA n = 4	Cohort 1: Vehicle 2000 cm^2 BSA n = 2	Cohort 2: PF-07038124 4000 cm^2 BSA n = 4	Cohort 2: Vehicle 4000 cm^2 BSA n = 2	Pooled Vehicle n = 4
TEAEs	0	0	1	0	0
SAEs	0	0	0	0	0

Population analysed: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.

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

Time frame: Day 1 up to Day 11. Count of participants. Unit: Participants

Measure	Cohort 1: PF-07038124 2000 cm^2 BSA n = 4	Cohort 1: Vehicle 2000 cm^2 BSA n = 2	Cohort 2: PF-07038124 4000 cm^2 BSA n = 4	Cohort 2: Vehicle 4000 cm^2 BSA n = 2	Pooled Vehicle n = 4
Value	0	0	0	0	0

Population analysed: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.

Primary outcome: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study

Time frame: Day 1 up to Day 11. Count of participants. Unit: Participants

Measure	Cohort 1: PF-07038124 2000 cm^2 BSA n = 4	Cohort 1: Vehicle 2000 cm^2 BSA n = 2	Cohort 2: PF-07038124 4000 cm^2 BSA n = 4	Cohort 2: Vehicle 4000 cm^2 BSA n = 2	Pooled Vehicle n = 4
Value	0	0	0	0	0

Population analysed: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.

Primary outcome: Number of Participants With Clinically Significant Laboratory Abnormalities

Time frame: Day 1 up to Day 11. Count of participants. Unit: Participants

Measure	Cohort 1: PF-07038124 2000 cm^2 BSA n = 4	Cohort 1: Vehicle 2000 cm^2 BSA n = 2	Cohort 2: PF-07038124 4000 cm^2 BSA n = 4	Cohort 2: Vehicle 4000 cm^2 BSA n = 2	Pooled Vehicle n = 4
Value	0	0	0	0	0

Population analysed: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: PF-07038124 2000 cm^2 BSA	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Cohort 1: Vehicle 2000 cm^2 BSA	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Cohort 2: PF-07038124 4000 cm^2 BSA	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Cohort 2: Vehicle 4000 cm^2 BSA	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Pooled Vehicle	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40820616Ono R, Wada S, Matsuoka N, Tsunemi Y, Furihata K. Phase 1 Study of Topical Administration of Novel Phosphodiesterase-4 Inhibitor PF-07038124 in Japanese Healthy Participants. J Dermatol. 2025 Nov;52(11):1666-1673. doi: 10.1111/1346-8138.17914. Epub 2025 Aug 17.
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 of Healthy, run by Pfizer at 1 site in Japan.

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 6 inclusion and 23 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 25 Jan 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 Japan. 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 25 Jan 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 With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)). The study lists 5 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 NCT04863417, which also lists 1 linked publication.

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 25 Jan 2024.