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
Overview
- Phase
- Phase 1
- Intervention
- PF-07275315
- Conditions
- Healthy Volunteers
- Sponsor
- Pfizer
- Enrollment
- 65
- Locations
- 4
- Primary Endpoint
- Number of participants with clinically meaningful change from baseline in vital signs
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Active
PF-07275315
Intervention: PF-07275315
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with clinically meaningful change from baseline in vital signs
Time Frame: Baseline through study completion, approximately 561 days
Number of participants with change from baseline in vital signs
Number of participants with Serious AEs (SAEs)
Time Frame: Baseline through study completion, approximately 561 days
Incidence and severity of SAEs
Number of participants with clinically meaningful change from baseline in ECG parameters
Time Frame: Baseline through study completion, approximately 561 days
number of participants with change from baseline in ECG parameters
Number of participants with Adverse Events (AEs)
Time Frame: Baseline through study completion, approximately 561 days
Incidence and severity of AEs
Number of participants with clinically meaningful change from baseline in laboratory Tests Results
Time Frame: Baseline through study completion, approximately 561 days
Number of Participants With Change From Baseline in Laboratory Tests Results
Secondary Outcomes
- Time to Maximum Plasma Concentration (Tmax) of PF-07275315(1 - 561 Days)
- AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours(1-561 days)
- Incidence of the development of neutralizing antibodies (NAb) against PF-07275315(1-561 days)
- Maximum Plasma Concentration (Cmax)(1- 561 Days)
- Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time(1-561 days)
- Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315(1 - 561 Days)
- Incidence of the development of Antidrug antibodies (ADA) against PF-07275315(1 - 561 Days)
- Half-life of PF-07275315(1-561 days)