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NCT04535167 · ClinicalTrials.gov registry record · Phase 1

First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.

A Phase 1 study, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT04535167: Completed Phase 1 study, sponsored by Pfizer.

NCT04535167 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04535167, a Phase 1 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection.

Primary Outcome

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical e

Interventions

  • DRUG Placebo
  • DRUG PF-07304814

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2020-09-09
Est. Completion 2021-06-07
Phase Phase 1
Pfizer

1,845 total trials

What the finished NCT04535167 record still lists

NCT04535167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04535167 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04535167 about?

NCT04535167 is a clinical study titled "First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.". It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection.

What is the current status of trial NCT04535167?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-09-09. Estimated completion is 2021-06-07.

What interventions are being tested in trial NCT04535167?

The interventions under investigation include: Placebo (DRUG), PF-07304814 (DRUG).

Who is sponsoring clinical trial NCT04535167?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04535167's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04535167, the US trial registry maintained by the National Library of Medicine. NCT04535167 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.