NCT04392219

COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of EIDD-2801 Following Oral Administration to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Ridgeback Biotherapeutics, LP · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a First In Human study designed to assess the safety, tolerability and pharmacokinetics of EIDD-2801 in healthy human volunteers.

Detailed description

This is a randomized, double-blind, placebo-controlled, First-in-Human study designed to evaluate the safety, tolerability, and pharmacokinetics of EIDD-2801 following oral administration to healthy volunteers.

Conditions

• Coronavirus

Interventions

Type	Name	Description
DRUG	EIDD-2801	Part 1: Participants will be randomized to receive a single oral dose of EIDD-2801 or Placebo. Part 2: Two single oral doses of EIDD-2801 will be administered to participants, in an open-label manner. Part 3: Participants will be randomized to receive twice daily dosing either EIDD-2801 or Placebo.
DRUG	Placebo	Part 1: Participants will be randomized to receive a single oral dose of EIDD-2801 or Placebo. Part 3: Participants will be randomized to receive twice daily dosing either EIDD-2801 or Placebo.

Timeline

• Start date: 2020-04-10
• Primary completion: 2020-08-11
• Completion: 2020-08-11
• First posted: 2020-05-18
• Last updated: 2021-07-19
• Results posted: 2021-07-19

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study