NCT04535167

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 1B, 2-PART, DOUBLE-BLIND, PLACEBO-CONTROLLED, SPONSOR-OPEN STUDY, TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE ASCENDING (24-HOUR, PART 1) AND MULTIPLE ASCENDING (120-HOUR, PART 2) INTRAVENOUS INFUSIONS OF PF-07304814 IN HOSPITALIZED PARTICIPANTS WITH COVID-19

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It is a 2-part study in hospitalized COVID-19 patients. * Part 1 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF-07304814 given as 24-hour IV infusion. 2 planned and 3 optional cohorts with 8 participants each are planned. * Part 2 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF- 07304814 given as 120-hour infusion. 2 planned and 2 optional cohorts with 8 participants each are planned

Conditions

• Viral Disease

Interventions

Type	Name	Description
DRUG	PF-07304814	PF-07304814 is an anti-viral, formulated for intravenous delivery
DRUG	Placebo	Placebo will be formulated for intravenous delivery

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-06-07
• Completion: 2021-06-07
• First posted: 2020-09-01
• Last updated: 2023-05-03
• Results posted: 2023-05-03

Locations

13 sites across 4 countries: United States, Belgium, Brazil, Spain

Regulatory

• FDA-regulated drug study