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

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).

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-07275315; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201107
      • Huashan Hospital,Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Key Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
2. 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.
3. Evidence of active, latent, untreated or inadequately treated infection with Mycobacterium tuberculosis (TB).
4. Participants with any acute or chronic infections or infection history as per protocol required.
5. History of fever within 7 days prior to dosing.
6. Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
7. 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.
8. Use of prohibited concomitant medication within 7 days or 5 half-lives (whichever is longer) prior to the administration of PF-07275315.
9. 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.
10. A positive urine drug test.
11. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) following at least 5 minutes of supine rest.
12. Standard 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
13. Participants with any protocol defined abnormalities in clinical laboratory tests at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-07275315; Participants will receive a single dose of PF-07275315 via IV infusion	Drug: PF-07275315; PF-07275315 solution for injection (single use only)
Placebo Comparator: Placebo; Participants will receive a single dose of placebo via IV infusion	Other: Placebo; Placebo solution for injection (single use only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Up to Day 181
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Up to Day 181
area under the concentration-time curve from time 0 to 336 hours (AUC336)	Up to Day 181
Area under the concentration-time curve from time 0 to infinity (AUCinf)	Up to Day 181
Area under the concentration-time curve from 0 to time of last measurable concentration (AUClast)	Up to Day 181
Terminal phase half-life (t½)	Up to Day 181
Incidence of treatment-emergent adverse events (TEAEs)	Up to Day 181
Incidence of treatment-emergent serious adverse events (SAEs)	Up to Day 181
Incidence of abnormal and clinically relevant changes in vital signs	Up to Day 181
Incidence of abnormal and clinically relevant changes in electrocardiogram	Up to Day 181
Incidence of abnormal and clinically relevant changes in laboratory assessments	Up to Day 181

Secondary Outcome Measures

Outcome Measure	Time Frame
Clearance (CL) of PF-07275315	Up to Day 181
volume of distribution (Vss)	Up to Day 181
mean residence time (MRT)	Up to Day 181
Incidence of the Development of Anti-Drug Antibodies (ADA) against PF-07275315	Up to Day 181
Incidence of the neutralizing antibodies (NAb) against PF-07275315, if appropriate and feasible	Up to Day 181
Change from baseline in serum levels of chemokine (C-C motif) ligand 17 (CCL17) / thymus and activation regulated chemokine (TARC)	Up to Day 181
Change from baseline in serum levels of total immunoglobulin E (IgE)	Up to Day 181

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Actual): July 14, 2025
• Study Completion (Actual): July 14, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: C4531004; NCT06675188 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes