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

NCT06675188 | Completed Phase 1 FDA Drug

• 2 other identifiers: C4531004NCT06675188
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.
• 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (7)

• 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

Study Arms (2)

PF-07275315

EXPERIMENTAL

Participants will receive a single dose of PF-07275315 via IV infusion

Drug: PF-07275315

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo via IV infusion

Other: Placebo

Interventions

PF-07275315 DRUG

PF-07275315 solution for injection (single use only)

PF-07275315

Placebo OTHER

Placebo solution for injection (single use only)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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-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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, 201107, China

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: January 6, 2025
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)