Clinical trial NCT06821750: A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults
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 SUBCUTANEOUS DOSES OF PF-07314470 IN HEALTHY PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-02-12
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people.


Eligibility criteria: Key Inclusion Criteria:

* Healthy males aged 18 to 45 years and healthy females aged 18 to 55 years
* Body Mass Index (BMI) of 16-32 kg/m2, and a total body weight greater than 50 kg (110 lb); for Japanese participants only, a total body weight greater than 45 kg
* for Japanese participants only, enrolling as Japanese must have 4 biological grandparents who were born in Japan.

Key Exclusion Criteria:

* Evidence or history of clinically significant medical or psychiatric conditions
* Prior or current use of any prohibited medications
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
* Pregnant or breastfeeding females, males with partners currently pregnant, or males or females pursuing artificial reproductive technologies
* Use of tobacco/nicotine containing products

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events Following Single Doses
timeFrame: Day 1 up to approximately Day 35
measure: Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Single Doses
timeFrame: Baseline up to approximately Day 35
measure: Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Single Doses
timeFrame: Baseline up to approximately Day 35
measure: Number of Participants with Clinically Significant Change from Baseline in ECGs Following Single Doses
timeFrame: Baseline up to approximately Day 35
measure: Number of Participants with Treatment Emergent Adverse Events Following Multiple Doses
timeFrame: Day 1 up to approximately Day 64
measure: Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Multiple Doses
timeFrame: Baseline up to approximately Day 64
measure: Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Multiple Doses
timeFrame: Baseline up to approximately Day 64
measure: Number of Participants with Clinically Significant Change from Baseline in ECGs Following Multiple Doses
timeFrame: Baseline up to approximately Day 64
measure: Number of Participants with Serious Adverse Events Following Single Doses
timeFrame: Day 1 up to approximately Day 35
measure: Number of Participants with Serious Adverse Events Following Multiple Doses
timeFrame: Day 1 up to approximately Day 64
Secondary outcomes:
measure: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of PF-07314470 Following Single Doses
timeFrame: Day 1 up to approximately Day 35
measure: Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Single Doses
timeFrame: Day 1 up to approximately Day 35
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Single Doses
timeFrame: Day 1 up to approximately Day 35
measure: Area Under the Serum Concentration-time Curve from Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07314470 Following Single Doses
timeFrame: Day 1 up to approximately Day 35
measure: Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Single Doses
timeFrame: Day 1 up to approximately Day 35
measure: Area Under the Serum Concentration-time Curve at Steady State Over the Dosing Interval (AUCtau) of PF-07314470 Following Multiple Doses
timeFrame: Day 1 up to approximately Day 64
measure: Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Multiple Doses
timeFrame: Day 1 up to approximately Day 64
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Multiple Doses
timeFrame: Day 1 up to approximately Day 64
measure: Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Multiple Doses
timeFrame: Day 1 up to approximately Day 64
measure: Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Single Doses
timeFrame: Day 1 up to approximately Day 35
measure: Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Single Doses
timeFrame: Day up to approximately Day 35
measure: Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Multiple Doses
timeFrame: Day 1 up to approximately Day 64
measure: Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Multiple Doses
timeFrame: Day 1 up to approximately Day 64
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit - New Haven
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: