NCT06003777

A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, CROSSOVER, FIRST-IN-HUMAN STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-06954522 IN HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (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-06954522) under study behave. And if there are any important side effects. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. The study will see 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 chosen by chance, like drawing names out of a hat to receive either: * study medicine (PF-06954522) * 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. The time frame of the study is approximately up to 36 days for each group and participants will stay at CRU for 20 days.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	PF-06954522	PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.
DRUG	Placebo	Placebo will be administered as oral suspensions as escalating single doses to be determined.

Timeline

• Start date: 2023-08-30
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2023-08-22
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study