NCT05907395

A Study to Learn About the Study Medicine (PF-07293893) at Different Dose Levels in Healthy Adults

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07293893 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purposes of the study are: To learn about the safety and tolerability of study medicine (PF-07293893). Tolerability is the extent to which side effects can be tolerated. Side effects are unwanted reactions to the study medicine. To measure the amount of PF-07293893 in blood after the medicine is taken by mouth. The study is seeking participants who: * Are females of non-childbearing potential and males 18 to 65 years of age * Are in generally healthy condition * Have not had viral infections (HIV, HBV or HCV). HIV, human immunodeficiency virus. HBV, human hepatitis B virus. HCV, human hepatitis C virus. Participants will receive either PF-07293893 or placebo (dummy pill) by chance. Participants will undergo up to 4 treatments periods in this study. Everyone will receive up to 4 doses of study medicine and up to 2 doses of placebo. In each period, participants will stay in study clinic for 5 days. There will be at least 2 days between each treatment period. Participants will be involved in this study for about 14 weeks. During their stay, participants will undergo several examinations. Participants will also have their blood collected by the study doctors for several times.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	PF-07293893	PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.
DRUG	Placebo	Matching placebo will be prepared as an oral suspension given in each cohort.

Timeline

• Start date: 2023-08-09
• Primary completion: 2024-03-22
• Completion: 2024-03-22
• First posted: 2023-06-18
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study