AzTrials
AzTrials

HealthyPhase 1NCT06675188

A Study to Learn More About the Study Medicine PF-07275315 in Healthy Chinese Adult Participants

A Phase 1 study testing PF-07275315 in people with Healthy, run by Pfizer at 1 site in China.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to learn if the study medicine (called PF-07275315) is safe and how it is processed in healthy Chinese participants. This study is seeking participants who: Are between 18 to 65 years of age. Are Chinese participants who are overtly 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
What is being tested?
PF-07275315
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
1 siteChina
Study dates
6 Jan 2025to 14 Jul 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male and female participants aged 18 to 65 years.
  • Body mass index (BMI) of 19-27.9 kilogram per meter squared, inclusive, and a total body weight >50 kilograms (110 pounds).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Capable of giving signed informed consent.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or syphilis; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb), or syphilis.
  • Evidence of active, latent, untreated or inadequately treated infection with Mycobacterium tuberculosis (TB).
  • Participants with any acute or chronic infections or infection history as per protocol required.
  • History of fever within 7 days prior to dosing.
  • Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
Show all 13Show fewer
  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Use of prohibited concomitant medication within 7 days or 5 half-lives (whichever is longer) prior to the administration of PF-07275315.
  • Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the administration of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
  • A positive urine drug test.
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) following at least 5 minutes of supine rest.
  • Standard 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • Participants with any protocol defined abnormalities in clinical laboratory tests at screening.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital,Fudan University

    Shanghai, Shanghai Municipality, 201107

Other trials in China

About this study

Official title: A Phase 1, Randomized, Double-Blind, Third-Party Open, Placebo-Controlled, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability, Immunogenicity, and Pharmacodynamics Following Intravenous Dose of PF-07275315 in Chinese Healthy Adult Participants

The purpose of this study is to learn if the study medicine (called PF-07275315) is safe and how it is processed in healthy Chinese participants. This study is seeking participants who:

  • Are between 18 to 65 years of age.
  • Are Chinese participants who are overtly healthy as determined by medical evaluation.
  • Have a BMI (body mass index) of 19 to 28 kilogram per meter squared; and a total body weight of more than50 kilograms (110 pounds).
Read more

All participants in this study will receive study medicine. About three-fourths will receive PF-07275315 and one-fourth will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The study medicine will be given as an IV infusion (directly into a vein) at the study clinic only one time.

The study will compare the experiences of people receiving PF-07275315 to those of people who do not. This will help see if PF-07275315 is safe and how it behaves inside the human body.

Participants will take part in this study for up to 181 days. During this time, the participants will stay at the study clinic for 5 days. After the stay, the participants will have 8 study visits at the study clinic.

Conditions
Healthy
Being tested
PF-07275315, Placebo

What participants receive

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

  • PF-07275315Drug

    PF-07275315 solution for injection (single use only)

  • PlaceboOther

    Placebo solution for injection (single use only)

Study groups in NCT06675188
Study groupRoleWhat they receive
PF-07275315ExperimentalParticipants will receive a single dose of PF-07275315 via IV infusion
Receives: Drug: PF-07275315
PlaceboPlacebo comparatorParticipants will receive a single dose of placebo via IV infusion
Receives: Other: Placebo

What is being measured

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

  1. Maximum Observed Plasma Concentration (Cmax)

    Measured: Up to Day 181

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Measured: Up to Day 181

  3. area under the concentration-time curve from time 0 to 336 hours (AUC336)

    Measured: Up to Day 181

  4. Area under the concentration-time curve from time 0 to infinity (AUCinf)

    Measured: Up to Day 181

  5. Area under the concentration-time curve from 0 to time of last measurable concentration (AUClast)

    Measured: Up to Day 181

  6. Terminal phase half-life (t½)

    Measured: Up to Day 181

  7. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: Up to Day 181

  8. Incidence of treatment-emergent serious adverse events (SAEs)

    Measured: Up to Day 181

  9. Incidence of abnormal and clinically relevant changes in vital signs

    Measured: Up to Day 181

  10. Incidence of abnormal and clinically relevant changes in electrocardiogram

    Measured: Up to Day 181

  11. Incidence of abnormal and clinically relevant changes in laboratory assessments

    Measured: Up to Day 181

Secondary outcomes (7)

  1. Clearance (CL) of PF-07275315

    Measured: Up to Day 181

  2. volume of distribution (Vss)

    Measured: Up to Day 181

  3. mean residence time (MRT)

    Measured: Up to Day 181

  4. Incidence of the Development of Anti-Drug Antibodies (ADA) against PF-07275315

    Measured: Up to Day 181

  5. Incidence of the neutralizing antibodies (NAb) against PF-07275315, if appropriate and feasible

    Measured: Up to Day 181

  6. Change from baseline in serum levels of chemokine (C-C motif) ligand 17 (CCL17) / thymus and activation regulated chemokine (TARC)

    Measured: Up to Day 181

  7. Change from baseline in serum levels of total immunoglobulin E (IgE)

    Measured: Up to Day 181

Timeline

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

  1. First posted5 Nov 2024
  2. Study start6 Jan 2025
  3. Primary completion14 Jul 2025
  4. Study completion14 Jul 2025

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06675188
Sponsor's protocol ID
C4531004
Other IDs
NCT06675188
Status last verified
Aug 2025
First submitted
4 Nov 2024
Last updated
3 Aug 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07275315 in people with Healthy, run by Pfizer at 1 site in China.

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 13 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 3 Aug 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 China. 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?

Maximum Observed Plasma Concentration (Cmax) (time frame: Up to Day 181). The study lists 11 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 NCT06675188.

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 3 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in