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

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: PF-07264660; Other: Placebo

• Registration Number: NCT06712082
• Lead Sponsor: Pfizer

Brief Summary

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.
...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Study Start: 2025-02-28
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

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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-07264660.
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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-07264660	PF-07264660	Participants will receive a single dose of PF-07264660 via IV infusion
Placebo	Placebo	Participants will receive a single dose of placebo via IV infusion

Primary Outcome Measures

Name	Time	Method
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Up to Day181
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
Maximum Observed Plasma Concentration (Cmax)	Up to Day 181

Secondary Outcome Measures

Name	Time	Method
Clearance (CL) of PF-07264660	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-07264660	Up to Day 181
Incidence of the neutralizing antibodies (NAb) against PF-07264660, 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