A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Biological: Placebo for PF-07314470; Biological: PF-07314470

Study type: Interventional

Funder types: Industry

Identifiers

NCT06821750

C5271001

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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23 participants in 4 patient groups, including a placebo group

PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14

Experimental group

Description:

Participants will receive a single dose of PF-07314470 at 1 of 7 dose levels

Treatment:

Biological: PF-07314470

Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14

Placebo Comparator group

Description:

Participants will receive a single dose of placebo for PF-07314470

Treatment:

Biological: Placebo for PF-07314470

PF-07314470; Cohorts 9 to 13

Experimental group

Description:

Participants will receive PF-07314470 weekly at 1 of 4 dose levels for 4 doses, or every 2 weeks at 1 dose level for 3 doses.

Treatment:

Biological: PF-07314470

Placebo for PF-07314470; Cohorts 9 to 13

Placebo Comparator group

Description:

Participants will receive placebo for PF-07314470 weekly for 4 doses, or every 2 weeks for 3 doses.

Treatment:

Biological: Placebo for PF-07314470