Healthy
Conditions
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.
Interventions
BIOLOGICALPF-07314470
subcutaneous injection
BIOLOGICALPlacebo for PF-07314470
subcutaneous injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events Following Single Doses | Day 1 up to approximately Day 35 |
| Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Single Doses | Baseline up to approximately Day 35 |
| Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Single Doses | Baseline up to approximately Day 35 |
| Number of Participants with Clinically Significant Change from Baseline in ECGs Following Single Doses | Baseline up to approximately Day 35 |
| Number of Participants with Treatment Emergent Adverse Events Following Multiple Doses | Day 1 up to approximately Day 64 |
| Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Multiple Doses | Baseline up to approximately Day 64 |
| Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Multiple Doses | Baseline up to approximately Day 64 |
| Number of Participants with Clinically Significant Change from Baseline in ECGs Following Multiple Doses | Baseline up to approximately Day 64 |
| Number of Participants with Serious Adverse Events Following Single Doses | Day 1 up to approximately Day 35 |
| Number of Participants with Serious Adverse Events Following Multiple Doses | Day 1 up to approximately Day 64 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Single Doses | Day up to approximately Day 35 | If appropriate |
| Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of PF-07314470 Following Single Doses | Day 1 up to approximately Day 35 | — |
| Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 | If appropriate |
| Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 | — |
| Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Single Doses | Day 1 up to approximately Day 35 | — |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Single Doses | Day 1 up to approximately Day 35 | — |
| Area Under the Serum Concentration-time Curve from Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07314470 Following Single Doses | Day 1 up to approximately Day 35 | If data permit |
| Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Single Doses | Day 1 up to approximately Day 35 | If data permit |
| Area Under the Serum Concentration-time Curve at Steady State Over the Dosing Interval (AUCtau) of PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 | — |
| Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 | — |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 | — |
| Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Multiple Doses | Day 1 up to approximately Day 64 | If data permit |
| Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Single Doses | Day 1 up to approximately Day 35 | — |
Countries
United States
Outcome results
None listed