NCT05890105

A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults

A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Crossover, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of PF-07853578 Administered to Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purposes of this study are: * To see how the new medicine (PF-07853578) under study is tolerated. And if there are any important side effects. And, how people feel after taking single increasing amount of the medicine by mouth. * To measure the amount of study medicine in your blood after the medicine is taken by mouth. This study is seeking for participants who: * are females of 18 to 65 years old and are not able to give birth to a child. * are males of 18 to 65 years old. * have body mass index of 16 to 31 kilograms per meter squared. * have a total body weight of more than 50 kilograms (110 pounds). Participants will be randomly selected to receive either study medicine (PF-07853578) or placebo (a pill that has no medicine in it). Participants may receive up to 4 amounts of study medicine and up to 2 amounts of placebo.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	PF-07853578	PF-07853578 will be administered as oral solutions or suspensions as escalating single doses to be determined.
DRUG	Placebo	Placebo will be administered as oral solutions or suspensions as escalating single doses to be determined.

Timeline

• Start date: 2023-06-02
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-06-06
• Last updated: 2025-01-03
• Results posted: 2025-01-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study