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Antiviral

Cohort 3 for Healthy Subjects

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 0 hour to 48-72 hours post dose
Awards & highlights

Study Summary

This trial studies the safety, tolerability and how the body processes a new drug called PF-07328948 when given in different doses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 0 hour to 48-72 hours post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 0 hour to 48-72 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AEs following single ascending dose (SAD)
Change From Baseline in Electrocardiogram (ECG) Parameters
Number of Participants With Abnormal Electrocardiogram (ECG)
+2 more
Secondary outcome measures
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf)
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast)
Maximum concentration observed in plasma (Cmax)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined.
Group II: Cohort 2Experimental Treatment2 Interventions
Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined.
Group III: Cohort 1Experimental Treatment2 Interventions
Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
PF-07328948
2022
Completed Phase 1
~20

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
10,911,854 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,022 Total Patients Enrolled

Frequently Asked Questions

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

What potential harms does Cohort 3 pose to individuals?

"With limited data available to support its safety and efficacy, Cohort 3 receives a score of 1 for safety on our evaluation scale."

Answered by AI

Is this medical research study recruiting elderly participants?

"Staying in line with the trial's criteria, candidates must be between 18 and 60 years of age to qualify for enrollment."

Answered by AI

What criteria must be met for an individual to become a participant in this research study?

"To be eligible, potential candidates must have healthy subjects (hs) and they need to fall within the 18-60 year old age bracket. This clinical trial is admitting approximately 24 patients."

Answered by AI

How many individuals are engaging in this experiment?

"Affirmative. According to information posted on clinicaltrials.gov, the trial which began recruiting participants after 17th October 2022 is still searching for 24 volunteers across one medical facility. The most recent modification to this study was made 15th December 2022."

Answered by AI

Is an enrollment process for participants currently underway for this experiment?

"Yes, the data hosted on clinicaltrials.gov verifies that this research study, initially posted on October 17th 2022 is actively recruiting participants. 24 individuals from a single site need to be recruited for successful completion of the trial."

Answered by AI

What are the main goals of this investigation?

"Over the 8 day period, this clinical trial will assess the number of patients exhibiting laboratory abnormalities. Secondary measurements that may be collected include Area Under the Curve (AUCinf and AUClast) as well as Terminal Half-Life (t1/2)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants
2022. "A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05654181.
~8 spots leftby Apr 2025
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