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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Intervention / Treatment
-----------------
* Drug: EIDD-2801
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between the ages of 18 and 60, inclusive. Female participants must be of non-childbearing 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/m^2. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EIDD-2801<br>EIDD-2801: Part 1: Participants were randomized to receive 50 to 1600 mg EIDD-2801 powder-in bottle (fasted); Part 2: Participants were randomized to receive two single 200 mg doses (fed or fasted); Part 3: Participants were randomized to receive twice daily doses of EIDD-2801 in an open-label manner. | Drug: EIDD-2801<br>* 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.<br>* Other names: Molnupiravir;|
| Placebo Comparator: Placebo<br>Placebo: Part 1: Participants were randomized to receive placebo (fasted); Part 3: Participants were randomized to receive placebo (fasted). | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following a single dose of EIDD-2801 in Part 1 | From screening through study completion, up to 15 days | 
| Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following multiple doses of EIDD-2801 in Part 3 | From screening through study completion, up to 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronavirus, EIDD-2801, ribonucleoside