HealthyPhase 1NCT06821750
A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults
A Phase 1 study testing PF-07314470 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-07314470
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 18 Aug 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males aged 18 to 45 years and healthy females aged 18 to 55 years
- Body Mass Index (BMI) of 16-32 kg/m2, and a total body weight greater than 50 kg (110 lb); for Japanese participants only, a total body weight greater than 45 kg
- for Japanese participants only, enrolling as Japanese must have 4 biological grandparents who were born in Japan.
Who cannot join
- Evidence or history of clinically significant medical or psychiatric conditions
- Prior or current use of any prohibited medications
- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
- Pregnant or breastfeeding females, males with partners currently pregnant, or males or females pursuing artificial reproductive technologies
- Use of tobacco/nicotine containing products
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, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE SUBCUTANEOUS DOSES OF PF-07314470 IN HEALTHY PARTICIPANTS
The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people.
- Conditions
- Healthy
- Being tested
- PF-07314470, Placebo for PF-07314470
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07314470Biological
subcutaneous injection
Placebo for PF-07314470Biological
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14 | Experimental | Participants will receive a single dose of PF-07314470 at 1 of 7 dose levels Receives: Biological: PF-07314470 |
| Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14 | Placebo comparator | Participants will receive a single dose of placebo for PF-07314470 Receives: Biological: Placebo for PF-07314470 |
| PF-07314470; Cohorts 9 to 13 | Experimental | Participants will receive PF-07314470 weekly at 1 of 4 dose levels for 4 doses, or every 2 weeks at 1 dose level for 3 doses. Receives: Biological: PF-07314470 |
| Placebo for PF-07314470; Cohorts 9 to 13 | Placebo comparator | Participants will receive placebo for PF-07314470 weekly for 4 doses, or every 2 weeks for 3 doses. Receives: Biological: Placebo for PF-07314470 |
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 Following Single Doses
Measured: Day 1 up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Single Doses
Measured: Baseline up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Single Doses
Measured: Baseline up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in ECGs Following Single Doses
Measured: Baseline up to approximately Day 35
Number of Participants with Treatment Emergent Adverse Events Following Multiple Doses
Measured: Day 1 up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Multiple Doses
Measured: Baseline up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Multiple Doses
Measured: Baseline up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in ECGs Following Multiple Doses
Measured: Baseline up to approximately Day 64
Number of Participants with Serious Adverse Events Following Single Doses
Measured: Day 1 up to approximately Day 35
Number of Participants with Serious Adverse Events Following Multiple Doses
Measured: Day 1 up to approximately Day 64
Secondary outcomes (13)
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of PF-07314470 Following Single Doses
Measured: Day 1 up to approximately Day 35
Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Single Doses
Measured: Day 1 up to approximately Day 35
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Single Doses
Measured: Day 1 up to approximately Day 35
Area Under the Serum Concentration-time Curve from Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07314470 Following Single Doses
If data permit
Measured: Day 1 up to approximately Day 35
Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Single Doses
If data permit
Measured: Day 1 up to approximately Day 35
Area Under the Serum Concentration-time Curve at Steady State Over the Dosing Interval (AUCtau) of PF-07314470 Following Multiple Doses
Measured: Day 1 up to approximately Day 64
Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Multiple Doses
Measured: Day 1 up to approximately Day 64
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Multiple Doses
Measured: Day 1 up to approximately Day 64
Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Multiple Doses
If data permit
Measured: Day 1 up to approximately Day 64
Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Single Doses
Measured: Day 1 up to approximately Day 35
Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Single Doses
If appropriate
Measured: Day up to approximately Day 35
Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Multiple Doses
Measured: Day 1 up to approximately Day 64
Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Multiple Doses
If appropriate
Measured: Day 1 up to approximately Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start11 Feb 2025
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Why it stopped: The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 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
- NCT06821750
- Sponsor's protocol ID
- C5271001
- Status last verified
- Oct 2025
- First submitted
- 6 Feb 2025
- Last updated
- 22 Oct 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 22 Oct 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 SUBCUTANEOUS DOSES OF PF-07314470 IN HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06821750
- Acronym / sponsor ID
- C5271001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 12 Feb 2025 (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 if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14 | Experimental | Biological: PF-07314470Participants will receive a single dose of PF-07314470 at 1 of 7 dose levels |
| Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14 | Placebo comparator | Biological: Placebo for PF-07314470Participants will receive a single dose of placebo for PF-07314470 |
| PF-07314470; Cohorts 9 to 13 | Experimental | Biological: PF-07314470Participants will receive PF-07314470 weekly at 1 of 4 dose levels for 4 doses, or every 2 weeks at 1 dose level for 3 doses. |
| Placebo for PF-07314470; Cohorts 9 to 13 | Placebo comparator | Biological: Placebo for PF-07314470Participants will receive placebo for PF-07314470 weekly for 4 doses, or every 2 weeks for 3 doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males aged 18 to 45 years and healthy females aged 18 to 55 years
- Body Mass Index (BMI) of 16-32 kg/m2, and a total body weight greater than 50 kg (110 lb); for Japanese participants only, a total body weight greater than 45 kg
- for Japanese participants only, enrolling as Japanese must have 4 biological grandparents who were born in Japan.
Key exclusion criteria (5 listed)
- Evidence or history of clinically significant medical or psychiatric conditions
- Prior or current use of any prohibited medications
- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
- Pregnant or breastfeeding females, males with partners currently pregnant, or males or females pursuing artificial reproductive technologies
- Use of tobacco/nicotine containing products
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-07314470subcutaneous injection | Biological | PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14, PF-07314470; Cohorts 9 to 13 |
| Placebo for PF-07314470subcutaneous injection | Biological | Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14, Placebo for PF-07314470; Cohorts 9 to 13 |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events Following Single Doses
Time frame: Day 1 up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Single Doses
Time frame: Baseline up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Single Doses
Time frame: Baseline up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in ECGs Following Single Doses
Time frame: Baseline up to approximately Day 35
Number of Participants with Treatment Emergent Adverse Events Following Multiple Doses
Time frame: Day 1 up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Multiple Doses
Time frame: Baseline up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Multiple Doses
Time frame: Baseline up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in ECGs Following Multiple Doses
Time frame: Baseline up to approximately Day 64
Number of Participants with Serious Adverse Events Following Single Doses
Time frame: Day 1 up to approximately Day 35
Number of Participants with Serious Adverse Events Following Multiple Doses
Time frame: Day 1 up to approximately Day 64
13 secondary outcomes
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of PF-07314470 Following Single Doses
Time frame: Day 1 up to approximately Day 35
Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Single Doses
Time frame: Day 1 up to approximately Day 35
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Single Doses
Time frame: Day 1 up to approximately Day 35
Area Under the Serum Concentration-time Curve from Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07314470 Following Single Doses
Time frame: Day 1 up to approximately Day 35
Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Single Doses
Time frame: Day 1 up to approximately Day 35
Area Under the Serum Concentration-time Curve at Steady State Over the Dosing Interval (AUCtau) of PF-07314470 Following Multiple Doses
Time frame: Day 1 up to approximately Day 64
Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Multiple Doses
Time frame: Day 1 up to approximately Day 64
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Multiple Doses
Time frame: Day 1 up to approximately Day 64
Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Multiple Doses
Time frame: Day 1 up to approximately Day 64
Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Single Doses
Time frame: Day 1 up to approximately Day 35
Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Single Doses
Time frame: Day up to approximately Day 35
Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Multiple Doses
Time frame: Day 1 up to approximately Day 64
Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Multiple Doses
Time frame: Day 1 up to approximately Day 64
Results and safety
The study was stopped early (reason given: The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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
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-07314470 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 22 Oct 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 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 was stopped early (reason given: The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.). Results are not available in the source record.
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 Following Single Doses (time frame: Day 1 up to approximately Day 35). The study lists 10 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 22 Oct 2025.