Clinical trial NCT05411588: A Study to Learn How the Study Medicine Called PF-07275315 Works in Healthy People
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE INTRAVENOUS AND SUBCUTANEOUS DOSES OF PF-07275315 IN HEALTHY PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: PF-07275315
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants.

This study is seeking participants who:

* Are healthy as determined by medical evaluation.
* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square - a total body weight of more than 50 kilograms (110 pounds)

Participants will be divided randomly into 8 different groups. All participants will receive either one PF-07275315 or a harmless treatment that has no medical effect (placebo) intravenous (IV) infusion (given directly into a vein). Participants will take part in this study for up to 541 days. During this time, eligible participants will receive single increasing amounts of PF-07275315 or placebo. Increase will only occur if the sponsor agrees that the next dose is likely to have acceptable safety and tolerability. The follow-up visit will take place 271 days after first treatment.

Detailed description: This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple escalating doses of PF-07275315 that will be conducted in healthy adults.

Eligibility criteria: This study is seeking participants who:

* Are overtly healthy as determined by medical evaluation.
* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Have a body mass index (BMI) of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 lb).

This study is not seeking participants who have:

* Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
* Any of the following acute or chronic infections or infection history
* Any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
* Have undergone significant trauma or major surgery within 1 month of the first dose of study drug.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Baseline through study completion, approximately 561 days
measure: Number of participants with clinically meaningful change from baseline in laboratory Tests Results
timeFrame: Baseline through study completion, approximately 561 days
measure: Number of participants with clinically meaningful change from baseline in vital signs
timeFrame: Baseline through study completion, approximately 561 days
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Baseline through study completion, approximately 561 days
measure: Number of participants with clinically meaningful change from baseline in ECG parameters
timeFrame: Baseline through study completion, approximately 561 days
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 1- 561 Days
measure: Time to Maximum Plasma Concentration (Tmax) of PF-07275315
timeFrame: 1 - 561 Days
measure: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315
timeFrame: 1 - 561 Days
measure: Incidence of the development of Antidrug antibodies (ADA) against PF-07275315
timeFrame: 1 - 561 Days
measure: Half-life of PF-07275315
timeFrame: 1-561 days
measure: Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time
timeFrame: 1-561 days
measure: AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours
timeFrame: 1-561 days
measure: Incidence of the development of neutralizing antibodies (NAb) against PF-07275315
timeFrame: 1-561 days
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit - Brussels
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: