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Completed

NCT Number: NCT06712082

A Study to Learn More About the Study Medicine PF-07264660 in Healthy Chinese Adult Participants

The purpose of this study is to learn if the study medicine (called PF-07264660) 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. Three-fourths will receive PF-07264660 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-07264660 to those of people who do not. This will help see if PF-07264660 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital,Fudan University, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Key Exclusion Criteria:

  • 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.
  • 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-07264660.
  • 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.

Treatment and study plan

PF-07264660

Drug

PF-07264660 solution for injection (single use only)

Placebo

Other

Placebo solution for injection (single use only)

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to Day 181

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

    Time frame: Up to Day181

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

    Time frame: Up to Day 181

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

    Time frame: Up to Day 181

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

    Time frame: Up to Day 181

  6. Terminal phase half-life (t½)

    Time frame: Up to Day 181

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

    Time frame: Up to Day 181

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

    Time frame: Up to Day 181

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

    Time frame: Up to Day 181

  10. Incidence of abnormal and clinically relevant changes in electrocardiogram

    Time frame: Up to Day 181

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

    Time frame: Up to Day 181

Secondary outcomes

  1. Clearance (CL) of PF-07264660

    Time frame: Up to Day 181

  2. volume of distribution (Vss)

    Time frame: Up to Day 181

  3. mean residence time (MRT)

    Time frame: Up to Day 181

  4. Incidence of the Development of Anti-Drug Antibodies (ADA) against PF-07264660

    Time frame: Up to Day 181

  5. Incidence of the neutralizing antibodies (NAb) against PF-07264660, if appropriate and feasible

    Time frame: 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)

    Time frame: Up to Day 181

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

    Time frame: Up to Day 181

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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-07264660 in Chinese Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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