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

  • STATUS
    Recruiting
  • participants needed
    130
  • sponsor
    Ridgeback Biotherapeutics, LP
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Updated on 5 August 2020
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body mass index
screening procedures
covid-19

Summary

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

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.

Details
Condition Coronavirus
Age 18years - 60years
Treatment Placebo, EIDD-2801
Clinical Study IdentifierNCT04392219
SponsorRidgeback Biotherapeutics, LP
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female between the ages of 18 and 60, inclusive
Female subjects must be of nonchildbearing potential
Male participants must agree to the use of effective contraception for study duration
Is in generally good health as determined by medical history, physical examinations (PEs) (at Screening and/or Check-in), vital signs, and other screening procedures
Has a body mass index (BMI) of 18 to 30 kg/m2

Exclusion Criteria

Females who are pregnant, planning to become pregnant, or breastfeeding
Has a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal (GI), hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as determined by the principal investigator (PI) (or designee)
Has any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders
Has a history of cancer (other than basal cell or squamous cell cancer of the skin), rheumatologic disease or blood dyscrasias
Has a history of gastrointestinal (GI) surgery or other condition that may interfere with absorption of study drug, in the opinion of the principal investigator (PI) (or designee)
Has a history of febrile illness within the 14 days prior to the first dose of study drug
Has a positive alcohol or drug screen at Screening or the Day -1 visit or has a history of alcohol or drug abuse within the past 5 years
Currently uses tobacco, nicotine or tobacco products or e-cigarettes, or stopped using tobacco products within the past 3 months
Has a total white cell count or absolute lymphocyte count outside the normal range, or hemoglobin or platelet levels below the lower limit of normal, at Screening or Day -1
Has values above the upper limit of normal for the following laboratory analytes: alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase (serum), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), at Screening or Day -1
Positive test result for human immunodeficiency virus (HIV), hepatitis b virus (HBV), or hepatitis c virus (HCV)
Has an autoimmune disease, is immunosuppressed or is in any way immunocompromised
Has any of the following
QT interval corrected for heart rate (using Fridericia's formula) (QTcF) >450 ms confirmed by repeat measurement
QRS duration >110 ms confirmed by repeat measurement
PR interval >220 ms confirmed by repeat measurements
findings which would make QTc measurements difficult or QTc data uninterpretable
history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
Except as noted, has used prescription drugs (other than hormone replacement therapy) within 14 days prior to the first dose of study drug unless, in the opinion of the PI (or designee), the drug will not interfere with study assessments
Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 3 months prior to the first dose of study drug and agrees not to receive another experimental agent during the duration of this trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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