HealthyPhase 1NCT07575906
A Study to Learn How a Single Dose of the Study Medicine Called PF-08057418 is Tolerated in the Body of Healthy Adults.
A Phase 1 study testing PF-08057418 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this clinical trial is to learn about the safety and pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from body after participant take it) of the study medicine (called PF-08057418) in healthy people. This study is seeking participants who are healthy adults. 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-08057418
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to 16 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Adults 18 to 60 years of age (or the minimum age of consent per local regulations) at screening.
- Healthy participants, as determined by medical history, physical examination, clinical laboratory tests, and cardiac monitoring.
- Body mass index (BMI) between 16 and 32 kg/m² and body weight >50 kg (110 lb).
- Willing and able to comply with all study procedures, including scheduled visits, treatment plans, laboratory testing, and lifestyle restrictions.
Who cannot join
- History or evidence of clinically significant medical conditions, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases (excluding untreated, asymptomatic seasonal allergies at the time of dosing).
- Any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy).
- History of HIV infection, hepatitis B, or hepatitis C, or positive screening tests for HIV, hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is permitted.
- History of phototoxicity or photosensitivity.
- Prior use of any investigational drug or vaccine within 30 days or 5 half-lives (whichever is longer) before the first study dose, or participation in another investigational study during this study.
- Elevated blood pressure at screening:
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- 140/90 mm Hg for participants <60 years, or
- 150/90 mm Hg for participants ≥60 years, after at least 5 minutes of supine rest (average of 3 measurements).
- Renal impairment, defined as estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m².
- Clinically significant ECG abnormalities, including but not limited to QT corrected for heart rate by Fridericia's cube root formula (QTcF) >450 ms, complete left bundle branch block, evidence of myocardial infarction or ischemia, second- or third-degree AV block, or clinically significant arrhythmias.
- Clinically significant laboratory abnormalities at screening, including ALT, AST, or total bilirubin ≥1.05 × ULN (participants with Gilbert's syndrome may be eligible if direct bilirubin is ≤ULN).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Clinical Research Unit -New Haven
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF SINGLE ASCENDING ORAL DOSES OF PF-08057418 IN HEALTHY ADULT PARTICIPANTS
The purpose of this clinical trial is to learn about the safety and pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from body after participant take it) of the study medicine (called PF-08057418) in healthy people.
This study is seeking participants who are healthy adults.
Read more
Everyone who participates in this study will receive the study medicine. The study medicine may be given as a solution or as a tablet. Participants will be dosed once a week for 5 weeks.
The investigator will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe.
Participants will be involved in this study for up to 13 weeks from screening to follow-up visit. Participants stay in the study clinic for the 5 week dosing duration of the study, with two follow-up visits subsequently, either in person or by telephone call.
- Conditions
- Healthy
- Being tested
- PF-08057418, Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.)
- Keywords
- PF-08057418, SAD, Single Ascending Dose, FIH, Healthy Participants, small molecule, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08057418Drug
solution or tablet (fasted/fed)
Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.)Other
solution or tablet (fasted/fed)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive single oral solution or tablet dose(s) of placebo. Receives: Other: Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.) |
| PF-08057418 | Experimental | Participants will receive single oral solution or tablet dose(s) of PF-08057418 Receives: Drug: PF-08057418 |
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)
Assessment of TEAEs, SAEs, clinical laboratory values, vital signs, continuous cardiac monitoring and 12-lead ECGs
Measured: Up to 10 weeks
Secondary outcomes (3)
Pharmacokinetics (PK): Area under the concentration-time curve (AUC) of PF-08057418
Measured: Up to 10 weeks
PK: Maximum Observed Plasma Concentration (Cmax) of PF-08057418
Measured: Up to 10 weeks
PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-08057418
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start8 May 2026
- Primary completion16 Jul 2026
- Study completion16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575906
- Sponsor's protocol ID
- C6471002
- Status last verified
- Jul 2026
- First submitted
- 4 May 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. 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 STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF SINGLE ASCENDING ORAL DOSES OF PF-08057418 IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT07575906
- Acronym / sponsor ID
- C6471002
- Conditions
- Healthy
- Keywords
- PF-08057418, SAD, Single Ascending Dose, FIH, Healthy Participants, small molecule, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 May 2026 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
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 clinical trial is to learn about the safety and pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from body after participant take it) of the study medicine (called PF-08057418) in healthy people.
This study is seeking participants who are healthy adults.
Everyone who participates in this study will receive the study medicine. The study medicine may be given as a solution or as a tablet. Participants will be dosed once a week for 5 weeks.
The investigator will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe.
Participants will be involved in this study for up to 13 weeks from screening to follow-up visit. Participants stay in the study clinic for the 5 week dosing duration of the study, with two follow-up visits subsequently, either in person or by telephone call.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.)Participants will receive single oral solution or tablet dose(s) of placebo. |
| PF-08057418 | Experimental | Drug: PF-08057418Participants will receive single oral solution or tablet dose(s) of PF-08057418 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults 18 to 60 years of age (or the minimum age of consent per local regulations) at screening.
- Healthy participants, as determined by medical history, physical examination, clinical laboratory tests, and cardiac monitoring.
- Body mass index (BMI) between 16 and 32 kg/m² and body weight >50 kg (110 lb).
- Willing and able to comply with all study procedures, including scheduled visits, treatment plans, laboratory testing, and lifestyle restrictions.
Key exclusion criteria (11 listed)
- History or evidence of clinically significant medical conditions, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases (excluding untreated, asymptomatic seasonal allergies at the time of dosing).
- Any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy).
- History of HIV infection, hepatitis B, or hepatitis C, or positive screening tests for HIV, hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is permitted.
- History of phototoxicity or photosensitivity.
- Prior use of any investigational drug or vaccine within 30 days or 5 half-lives (whichever is longer) before the first study dose, or participation in another investigational study during this 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-08057418solution or tablet (fasted/fed) | Drug | PF-08057418 |
| Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.)solution or tablet (fasted/fed) | Other | Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 10 weeks
Assessment of TEAEs, SAEs, clinical laboratory values, vital signs, continuous cardiac monitoring and 12-lead ECGs
3 secondary outcomes
Pharmacokinetics (PK): Area under the concentration-time curve (AUC) of PF-08057418
Time frame: Up to 10 weeks
PK: Maximum Observed Plasma Concentration (Cmax) of PF-08057418
Time frame: Up to 10 weeks
PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-08057418
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- 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-08057418 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 4 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 24 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.