Coronavirus
Conditions
Keywords
Coronavirus, EIDD-2801, ribonucleoside
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.
Interventions
DRUGEIDD-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.
DRUGPlacebo
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
Ridgeback Biotherapeutics, LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | From screening through study completion, up to 15 days | Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following a single dose of EIDD-2801 in Part 1 |
| Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | From screening through study completion, up to 20 days | Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following multiple doses of EIDD-2801 in Part 3 |
Countries
United Kingdom
Participant flow
Pre-assignment details
The same 10 participants started and completed the Part 200 mg EIDD-2801 (Fasted) and Part 200 mg EIDD-2801 (Fed) arms.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 - Placebo Participants were randomized to receive a single oral dose of Placebo (fasted). | 16 |
| Part 1 - 50 mg EIDD-2801 Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted). | 6 |
| Part 1 - 100 mg EIDD-2801 Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted). | 6 |
| Part 1 - 200 mg EIDD-2801 Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted). | 6 |
| Part 1 - 400 mg EIDD-2801 Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted). | 6 |
| Part 1 - 600 mg EIDD-2801 Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted). | 6 |
| Part 1 - 800 mg EIDD-2801 Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted). | 6 |
| Part 1 - 1200 mg EIDD-2801 Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted). | 6 |
| Part 1 - 1600 mg EIDD-2801 Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted). | 6 |
| Part 2 - 200 mg EIDD-2801 (Fasted/Fed) Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted/fed). | 10 |
| Part 3 - Placebo Participants were randomized to receive two daily dosing of Placebo capsules (fasted). | 14 |
| Part 3 - 50 mg EIDD-2801 Participants were randomized to receive two daily dosing of 50 mg EIDD-2801 capsules (fasted). | 6 |
| Part 3 - 100 mg EIDD-2801 Participants were randomized to receive two daily dosing of 100 mg EIDD-2801 capsules (fasted). | 6 |
| Part 3 - 200 mg EIDD-2801 Participants were randomized to receive two daily dosing of 200 mg EIDD-2801 capsules (fasted). | 6 |
| Part 3 - 300 mg EIDD-2801 Participants were randomized to receive two daily dosing of 300 mg EIDD-2801 capsules (fasted). | 6 |
| Part 3 - 400 mg EIDD-2801 Participants were randomized to receive two daily dosing of 400 mg EIDD-2801 capsules (fasted). | 6 |
| Part 3 - 600 mg EIDD-2801 Participants were randomized to receive two daily dosing of 600 mg EIDD-2801 capsules (fasted). | 6 |
| Part 3 - 800 mg EIDD-2801 Participants were randomized to receive two daily dosing of 800 mg EIDD-2801 capsules (fasted). | 6 |
| Total | 130 |
Baseline characteristics
| Characteristic | Part 1 - Placebo | Part 1 - 50 mg EIDD-2801 | Part 1 - 100 mg EIDD-2801 | Part 1 - 200 mg EIDD-2801 | Part 1 - 400 mg EIDD-2801 | Part 1 - 600 mg EIDD-2801 | Part 1 - 800 mg EIDD-2801 | Part 1 - 1200 mg EIDD-2801 | Part 1 - 1600 mg EIDD-2801 | Part 2 - 200 mg EIDD-2801 (Fasted/Fed) | Part 3 - Placebo | Part 3 - 50 mg EIDD-2801 | Part 3 - 100 mg EIDD-2801 | Part 3 - 200 mg EIDD-2801 | Part 3 - 300 mg EIDD-2801 | Part 3 - 400 mg EIDD-2801 | Part 3 - 600 mg EIDD-2801 | Part 3 - 800 mg EIDD-2801 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.4 years | 52.0 years | 41.2 years | 39.8 years | 42.0 years | 38.2 years | 39.5 years | 34.2 years | 30.8 years | 45.3 years | 37.5 years | 34.0 years | 45.5 years | 36.8 years | 36.2 years | 38.8 years | 30.8 years | 30.8 years | 38.7 years |
| Body mass index | 24.80 kg/m^2 STANDARD_DEVIATION 2.217 | 26.07 kg/m^2 STANDARD_DEVIATION 2.649 | 23.50 kg/m^2 STANDARD_DEVIATION 3.501 | 26.68 kg/m^2 STANDARD_DEVIATION 2.32 | 24.48 kg/m^2 STANDARD_DEVIATION 2.349 | 25.32 kg/m^2 STANDARD_DEVIATION 1.847 | 26.45 kg/m^2 STANDARD_DEVIATION 2.745 | 25.15 kg/m^2 STANDARD_DEVIATION 1.623 | 23.37 kg/m^2 STANDARD_DEVIATION 2.954 | 25.38 kg/m^2 STANDARD_DEVIATION 2.185 | 24.79 kg/m^2 STANDARD_DEVIATION 2.681 | 22.27 kg/m^2 STANDARD_DEVIATION 3.371 | 24.97 kg/m^2 STANDARD_DEVIATION 4.162 | 25.50 kg/m^2 STANDARD_DEVIATION 3.117 | 24.48 kg/m^2 STANDARD_DEVIATION 1.901 | 24.32 kg/m^2 STANDARD_DEVIATION 2.866 | 24.50 kg/m^2 STANDARD_DEVIATION 3.679 | 24.20 kg/m^2 STANDARD_DEVIATION 2.504 | 24.81 kg/m^2 STANDARD_DEVIATION 2.707 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 9 Participants | 13 Participants | 6 Participants | 6 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 5 Participants | 122 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 4 Participants | 4 Participants | 5 Participants | 4 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 12 Participants | 5 Participants | 5 Participants | 6 Participants | 4 Participants | 5 Participants | 6 Participants | 6 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 10 | 0 / 10 | 0 / 14 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 7 / 16 | 2 / 6 | 0 / 6 | 3 / 6 | 3 / 6 | 4 / 6 | 2 / 6 | 1 / 6 | 2 / 6 | 2 / 10 | 1 / 10 | 7 / 14 | 2 / 6 | 3 / 6 | 3 / 6 | 2 / 6 | 3 / 6 | 2 / 6 | 3 / 6 |
| serious Total, serious adverse events | 0 / 16 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 10 | 0 / 10 | 0 / 14 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
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
Time frame: From screening through study completion, up to 15 days
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 - Placebo | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 7 Participants |
| Part 1 - Placebo | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 7 Participants |
| Part 1 - Placebo | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 1 Participants |
| Part 1 - Placebo | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 50 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 50 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 2 Participants |
| Part 1 - 50 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 2 Participants |
| Part 1 - 50 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 100 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 0 Participants |
| Part 1 - 100 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 100 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 100 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 0 Participants |
| Part 1 - 200 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 3 Participants |
| Part 1 - 200 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 3 Participants |
| Part 1 - 200 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 200 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 400 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 1 Participants |
| Part 1 - 400 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 3 Participants |
| Part 1 - 400 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 3 Participants |
| Part 1 - 400 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 600 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 600 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 4 Participants |
| Part 1 - 600 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 600 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 4 Participants |
| Part 1 - 800 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 800 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 2 Participants |
| Part 1 - 800 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 800 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 2 Participants |
| Part 1 - 1200 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 1 Participants |
| Part 1 - 1200 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 1200 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 1200 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 1 Participants |
| Part 1 - 1600 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 2 Participants |
| Part 1 - 1600 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 1600 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 1600 mg EIDD-2801 | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 2 Participants |
Primary
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
Time frame: From screening through study completion, up to 20 days
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 - Placebo | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 7 Participants |
| Part 1 - Placebo | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 7 Participants |
| Part 1 - Placebo | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - Placebo | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 50 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 50 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 2 Participants |
| Part 1 - 50 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 2 Participants |
| Part 1 - 50 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 100 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 3 Participants |
| Part 1 - 100 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 100 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 3 Participants |
| Part 1 - 100 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 200 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 3 Participants |
| Part 1 - 200 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 3 Participants |
| Part 1 - 200 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 1 Participants |
| Part 1 - 200 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 400 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 400 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 400 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 2 Participants |
| Part 1 - 400 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 2 Participants |
| Part 1 - 600 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 600 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 600 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 3 Participants |
| Part 1 - 600 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 3 Participants |
| Part 1 - 800 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 800 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 2 Participants |
| Part 1 - 800 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 800 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 2 Participants |
| Part 1 - 1200 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Mild (Grade 1) | 3 Participants |
| Part 1 - 1200 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Moderate (Grade 2) | 0 Participants |
| Part 1 - 1200 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | Severe (Grade 3) | 0 Participants |
| Part 1 - 1200 mg EIDD-2801 | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events | TEAEs (Overall) | 3 Participants |