CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
PF-06954522 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06003777
NCT06003777Phase 1Completed

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

Pfizer·interventional·Posted Aug 22, 2023·Updated Jun 24, 2025

In Brief

A Phase 1 clinical trial evaluating PF-06954522 and Placebo for Healthy Participants. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedAug 22, 2023
Enrollment StartAug 30, 2023
Primary CompletionFeb 20, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.9 years ago

Interventions

PF-06954522drug

PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.

Placebodrug

Placebo will be administered as oral suspensions as escalating single doses to be determined.