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

NCT04392219 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-07-19

Study results available
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Summary

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

Conditions

  • Coronavirus

Interventions

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.

Sponsors & Collaborators

  • Ridgeback Biotherapeutics, LP

    lead INDUSTRY

Principal Investigators

  • Jim Bush, MBChB, PhD · Covance Clinical Research Unit Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-10
Primary Completion
2020-08-11
Completion
2020-08-11
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04392219 on ClinicalTrials.gov