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Study Medicine for Healthy Adults

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 0 hour to 72 hours post-dose in each period
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new medicine (PF-07853578) in people aged 18-65, with a BMI of 16-31 and body weight of 50kg+ to see if it has any important side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 0 hour to 72 hours post-dose in each period
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 0 hour to 72 hours post-dose in each period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Number of Participants With Clinical Laboratory Abnormalities
Number of Participants With Clinically Significant Change From Baseline in Telemetry Findings
+4 more
Secondary outcome measures
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07853578
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07853578
Maximum Observed Plasma Concentration (Cmax) of PF-07853578
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.
Group II: Cohort 2Experimental Treatment2 Interventions
Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.
Group III: Cohort 1Experimental Treatment2 Interventions
Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
PF-07853578
2023
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,850 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,018 Total Patients Enrolled

Media Library

Cohort 3 Clinical Trial Eligibility Overview. Trial Name: NCT05890105 — Phase 1
Healthy Subjects Research Study Groups: Cohort 3, Cohort 1, Cohort 2
Healthy Subjects Clinical Trial 2023: Cohort 3 Highlights & Side Effects. Trial Name: NCT05890105 — Phase 1
Cohort 3 2023 Treatment Timeline for Medical Study. Trial Name: NCT05890105 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Cohort 1 for therapeutic use?

"Cohort 1 was given a score of 1, as it is currently in Phase I. Thus far, there has been limited evidence to suggest its safety and efficacy."

Answered by AI

What is the size of the cohort currently participating in this trial?

"Affirmative. According to the clinicaltrials.gov database, this experiment is currently seeking participants after being first published on June 2nd 2023 and updated most recently on July 3rd 2023. 24 patients are needed for recruitment at a single medical centre."

Answered by AI

Is the enrollment for this experiment still open?

"Affirmative. The info found on clinicaltrials.gov validates that this research is currently recruiting patients, having been initially published on June 2nd 2023 and later updated on July 3rd 2023. 24 individuals will be accepted at a single site."

Answered by AI

Are individuals above the age of 50 being included in this trial's cohort?

"This trial is open to patients aged 18 and 65. For those younger than 18 or older than 65, there are 55 clinical trials available for the former age group and 368 studies dedicated to seniors."

Answered by AI

Is there a way for me to become involved in this experiment?

"This clinical trial is enrolling 24 adults aged 18 to 65, who are considered medically sound. Additional requisites for participation include being a female of non-childbearing potential or male, having a BMI between 16 and 30.5 kg/m2, and total body weight exceeding 50 kilograms (110 lbs)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults
2023. "A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05890105.
~13 spots leftby Apr 2025
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