Healthy VolunteersPhase 1NCT05411588
A Study to Learn How the Study Medicine Called PF-07275315 Works in Healthy People
A Phase 1 study testing PF-07275315 in people with Healthy Volunteers, run by Pfizer at 5 sites in 2 countries.
Trial summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants. This study is seeking participants who: Are healthy as determined by medical evaluation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PF-07275315
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 9 Jun 2022to 13 May 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
This study is seeking participants who:
- Are overtly healthy as determined by medical evaluation.
- Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Have a body mass index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lb).
This study is not seeking participants who have:
- Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
- Any of the following acute or chronic infections or infection history
- Any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- Have undergone significant trauma or major surgery within 1 month of the first dose of study drug.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Orange County Research Center
Lake Forest, California, 92630
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
Qps-Mra, Llc
South Miami, Florida, 33143
Orange County Research Center
Tustin, California, 92780
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE INTRAVENOUS AND SUBCUTANEOUS DOSES OF PF-07275315 IN HEALTHY PARTICIPANTS
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants.
This study is seeking participants who:
Read more
- Are healthy as determined by medical evaluation.
- Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square - a total body weight of more than 50 kilograms (110 pounds)
Participants will be divided randomly into 8 different groups. All participants will receive either one PF-07275315 or a harmless treatment that has no medical effect (placebo) intravenous (IV) infusion (given directly into a vein). Participants will take part in this study for up to 541 days. During this time, eligible participants will receive single increasing amounts of PF-07275315 or placebo. Increase will only occur if the sponsor agrees that the next dose is likely to have acceptable safety and tolerability. The follow-up visit will take place 271 days after first treatment.
Read the detailed description
This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple escalating doses of PF-07275315 that will be conducted in healthy adults.
- Conditions
- Healthy Volunteers
- Being tested
- PF-07275315, Placebo
- Keywords
- PF-07275315
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07275315Drug
Also called No other name
Active drug
PlaceboDrug
Also called No other name
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | PF-07275315 Receives: Drug: PF-07275315 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Incidence and severity of AEs
Measured: Baseline through study completion, approximately 561 days
Number of participants with clinically meaningful change from baseline in laboratory Tests Results
Number of Participants With Change From Baseline in Laboratory Tests Results
Measured: Baseline through study completion, approximately 561 days
Number of participants with clinically meaningful change from baseline in vital signs
Number of participants with change from baseline in vital signs
Measured: Baseline through study completion, approximately 561 days
Number of participants with Serious AEs (SAEs)
Incidence and severity of SAEs
Measured: Baseline through study completion, approximately 561 days
Number of participants with clinically meaningful change from baseline in ECG parameters
number of participants with change from baseline in ECG parameters
Measured: Baseline through study completion, approximately 561 days
Secondary outcomes (8)
Maximum Plasma Concentration (Cmax)
Cmax will be observed directly from data.
Measured: 1- 561 Days
Time to Maximum Plasma Concentration (Tmax) of PF-07275315
Tmax will be observed directly from data.
Measured: 1 - 561 Days
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
Measured: 1 - 561 Days
Incidence of the development of Antidrug antibodies (ADA) against PF-07275315
To evaluate the immunogenicity profile of PF-07275315 in healthy adults.
Measured: 1 - 561 Days
Half-life of PF-07275315
terminal elimination half-life will be measured
Measured: 1-561 days
Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time
AUCinf
Measured: 1-561 days
AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours
AUC336
Measured: 1-561 days
Incidence of the development of neutralizing antibodies (NAb) against PF-07275315
To evaluate the immunogenicity profile of PF-07275315 in healthy adults.
Measured: 1-561 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start9 Jun 2022
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 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
- NCT05411588
- Sponsor's protocol ID
- C4531001
- Other IDs
- 2022-000854-27
- Status last verified
- May 2025
- First submitted
- 6 Jun 2022
- Last updated
- 25 May 2025
- 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 25 May 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, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE INTRAVENOUS AND SUBCUTANEOUS DOSES OF PF-07275315 IN HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT05411588
- Acronym / sponsor ID
- C4531001
- Conditions
- Healthy Volunteers
- Keywords
- PF-07275315
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 9 Jun 2022 (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 effects of the study medicine (called PF-07275315) in healthy participants.
This study is seeking participants who:
- Are healthy as determined by medical evaluation.
- Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square - a total body weight of more than 50 kilograms (110 pounds)
Participants will be divided randomly into 8 different groups. All participants will receive either one PF-07275315 or a harmless treatment that has no medical effect (placebo) intravenous (IV) infusion (given directly into a vein). Participants will take part in this study for up to 541 days. During this time, eligible participants will receive single increasing amounts of PF-07275315 or placebo. Increase will only occur if the sponsor agrees that the next dose is likely to have acceptable safety and tolerability. The follow-up visit will take place 271 days after first treatment.
Detailed description
This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple escalating doses of PF-07275315 that will be conducted in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: PF-07275315PF-07275315 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
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-07275315Also: No other nameActive drug | Drug | Active |
| PlaceboAlso: No other namePlacebo | Drug | Placebo |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Baseline through study completion, approximately 561 days
Incidence and severity of AEs
Number of participants with clinically meaningful change from baseline in laboratory Tests Results
Time frame: Baseline through study completion, approximately 561 days
Number of Participants With Change From Baseline in Laboratory Tests Results
Number of participants with clinically meaningful change from baseline in vital signs
Time frame: Baseline through study completion, approximately 561 days
Number of participants with change from baseline in vital signs
Number of participants with Serious AEs (SAEs)
Time frame: Baseline through study completion, approximately 561 days
Incidence and severity of SAEs
Number of participants with clinically meaningful change from baseline in ECG parameters
Time frame: Baseline through study completion, approximately 561 days
number of participants with change from baseline in ECG parameters
8 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: 1- 561 Days
Time to Maximum Plasma Concentration (Tmax) of PF-07275315
Time frame: 1 - 561 Days
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315
Time frame: 1 - 561 Days
Incidence of the development of Antidrug antibodies (ADA) against PF-07275315
Time frame: 1 - 561 Days
Half-life of PF-07275315
Time frame: 1-561 days
Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time
Time frame: 1-561 days
AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours
Time frame: 1-561 days
Incidence of the development of neutralizing antibodies (NAb) against PF-07275315
Time frame: 1-561 days
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 25 May 2025.
- 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
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07275315 in people with Healthy Volunteers, run by Pfizer at 5 sites in 2 countries.
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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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. 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 Adverse Events (AEs) (time frame: Baseline through study completion, approximately 561 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?
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 May 2025.