COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers
Sponsor
Ridgeback Biotherapeutics, LP (Industry)
Overall Status
Completed
CT.gov ID
NCT04392219
Collaborator
(none)
130
1
2
4
32.2
Study Details
Study Description
Brief Summary
This is a First In Human study designed to assess the safety, tolerability and pharmacokinetics of EIDD-2801 in healthy human volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Apr 10, 2020
Actual Primary Completion Date
:
Aug 11, 2020
Actual Study Completion Date
:
Aug 11, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EIDD-2801 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
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.
Other Names:
|
| Placebo Comparator: Placebo Placebo: Part 1: Participants were randomized to receive placebo (fasted); Part 3: Participants were randomized to receive placebo (fasted). |
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.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Covance Leeds Clinical Research Unit | Leeds | United Kingdom |
Sponsors and Collaborators
- Ridgeback Biotherapeutics, LP
Investigators
- Principal Investigator: Jim Bush, MBChB, PhD, Covance Clinical Research Unit Limited
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Ridgeback Biotherapeutics, LP
ClinicalTrials.gov Identifier:
NCT04392219
Other Study ID Numbers:
- EIDD-2801-1001
- 2020-001407-17
First Posted:
May 18, 2020
Last Update Posted:
Jul 19, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ridgeback Biotherapeutics, LP
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The same 10 participants started and completed the Part 200 mg EIDD-2801 (Fasted) and Part 200 mg EIDD-2801 (Fed) arms. |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were randomized to receive a single oral dose of Placebo (fasted). | Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted). | Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted). | Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted/fed). | Participants were randomized to receive a twice daily dosing of Placebo capsules (fasted). | Participants were randomized to receive twice daily dosing of 50-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 100-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 200-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 300-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 400-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 600-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 800-mg EIDD-2801 capsules (fasted). |
| Period Title: Overall Study | ||||||||||||||||||
| STARTED | 16 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 10 | 14 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| COMPLETED | 16 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 10 | 14 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were randomized to receive a single oral dose of Placebo (fasted). | Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted). | Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted). | Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted/fed). | Participants were randomized to receive two daily dosing of Placebo capsules (fasted). | Participants were randomized to receive two daily dosing of 50 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive two daily dosing of 100 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive two daily dosing of 200 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive two daily dosing of 300 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive two daily dosing of 400 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive two daily dosing of 600 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive two daily dosing of 800 mg EIDD-2801 capsules (fasted). | Total of all reporting groups |
| Overall Participants | 16 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 10 | 14 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 130 |
| Age (years) [Mean (Full Range) ] | |||||||||||||||||||
| Mean (Full Range) [years] |
39.4
|
52.0
|
41.2
|
39.8
|
42.0
|
38.2
|
39.5
|
34.2
|
30.8
|
45.3
|
37.5
|
34.0
|
45.5
|
36.8
|
36.2
|
38.8
|
30.8
|
30.8
|
38.7
|
| Sex: Female, Male (Count of Participants) | |||||||||||||||||||
| Female |
2
12.5%
|
2
33.3%
|
2
33.3%
|
1
16.7%
|
2
33.3%
|
2
33.3%
|
0
0%
|
0
0%
|
0
0%
|
3
30%
|
2
14.3%
|
1
16.7%
|
1
16.7%
|
0
0%
|
2
33.3%
|
1
16.7%
|
0
0%
|
0
0%
|
21
16.2%
|
| Male |
14
87.5%
|
4
66.7%
|
4
66.7%
|
5
83.3%
|
4
66.7%
|
4
66.7%
|
6
100%
|
6
100%
|
6
100%
|
7
70%
|
12
85.7%
|
5
83.3%
|
5
83.3%
|
6
100%
|
4
66.7%
|
5
83.3%
|
6
100%
|
6
100%
|
109
83.8%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
1
16.7%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
4
3.1%
|
| White |
16
100%
|
6
100%
|
6
100%
|
6
100%
|
5
83.3%
|
6
100%
|
5
83.3%
|
6
100%
|
5
83.3%
|
9
90%
|
13
92.9%
|
6
100%
|
6
100%
|
5
83.3%
|
5
83.3%
|
6
100%
|
6
100%
|
5
83.3%
|
122
93.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
1
7.1%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
4
3.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Body mass index (kg/m^2) [Mean (Standard Deviation) ] | |||||||||||||||||||
| Mean (Standard Deviation) [kg/m^2] |
24.80
(2.217)
|
26.07
(2.649)
|
23.50
(3.501)
|
26.68
(2.320)
|
24.48
(2.349)
|
25.32
(1.847)
|
26.45
(2.745)
|
25.15
(1.623)
|
23.37
(2.954)
|
25.38
(2.185)
|
24.79
(2.681)
|
22.27
(3.371)
|
24.97
(4.162)
|
25.50
(3.117)
|
24.48
(1.901)
|
24.32
(2.866)
|
24.50
(3.679)
|
24.20
(2.504)
|
24.81
(2.707)
|
Outcome Measures
| Title | Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were randomized to receive a single oral dose of Placebo (fasted). | Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted). | Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted). |
| Measure Participants | 16 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| TEAEs (Overall) |
7
43.8%
|
2
33.3%
|
0
0%
|
3
50%
|
3
50%
|
4
66.7%
|
2
33.3%
|
1
16.7%
|
2
33.3%
|
| Mild (Grade 1) |
7
43.8%
|
2
33.3%
|
0
0%
|
3
50%
|
3
50%
|
4
66.7%
|
2
33.3%
|
1
16.7%
|
2
33.3%
|
| Moderate (Grade 2) |
1
6.3%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Severe (Grade 3) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were randomized to receive twice daily dosing of Placebo capsules (fasted). | Participants were randomized to receive twice daily dosing of 50 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 100 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 200 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 300 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 400 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 600 mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 800 mg EIDD-2801 capsules (fasted). |
| Measure Participants | 14 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| TEAEs (Overall) |
7
43.8%
|
2
33.3%
|
3
50%
|
3
50%
|
2
33.3%
|
3
50%
|
2
33.3%
|
3
50%
|
| Mild (Grade 1) |
7
43.8%
|
2
33.3%
|
3
50%
|
3
50%
|
2
33.3%
|
3
50%
|
2
33.3%
|
3
50%
|
| Moderate (Grade 2) |
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Severe (Grade 3) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) | |||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information. | |||||||||||||||||||||||||||||||||||||
| Arm/Group Title | 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) | Part 2 - 200 mg EIDD-2801 (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 | |||||||||||||||||||
| Arm/Group Description | Participants were randomized to receive a single oral dose of Placebo (fasted). | Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted). | Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted). | Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted). | Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted). | Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fed). | Participants were randomized to receive twice daily dosing of Placebo capsules (fasted). | Participants were randomized to receive twice daily dosing of 50-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 100-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 200-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 300-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 400-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 600-mg EIDD-2801 capsules (fasted). | Participants were randomized to receive twice daily dosing of 800-mg EIDD-2801 capsules (fasted). | |||||||||||||||||||
All Cause Mortality |
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| 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) | Part 2 - 200 mg EIDD-2801 (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 | ||||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
Serious Adverse Events |
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| 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) | Part 2 - 200 mg EIDD-2801 (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 | ||||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
Other (Not Including Serious) Adverse Events |
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| 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) | Part 2 - 200 mg EIDD-2801 (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 | ||||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/16 (43.8%) | 2/6 (33.3%) | 0/6 (0%) | 3/6 (50%) | 3/6 (50%) | 4/6 (66.7%) | 2/6 (33.3%) | 1/6 (16.7%) | 2/6 (33.3%) | 2/10 (20%) | 1/10 (10%) | 7/14 (50%) | 2/6 (33.3%) | 3/6 (50%) | 3/6 (50%) | 2/6 (33.3%) | 3/6 (50%) | 2/6 (33.3%) | 3/6 (50%) | |||||||||||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||||||||||||||||||
| Lymphadenopathy | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||||||||||||||||||||
| Ear pain | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Tinnitus | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Eye disorders | ||||||||||||||||||||||||||||||||||||||
| Abnormal sensation in eye | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Eye irritation | 0/16 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Ocular hyperaemia | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||||||||||||||||||
| Abdominal pain | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Abdominal pain upper | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Constipation | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Diarrhoea | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | |||||||||||||||||||
| Gastrointestinal sounds abnormal | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Mouth ulceration | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Nausea | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Vomiting | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| General disorders | ||||||||||||||||||||||||||||||||||||||
| Catheter site dryness | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Catheter site pain | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Catheter site rash | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Feeling hot | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Influenza like illness | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Medical device site erythema | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Medical device site reaction | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | |||||||||||||||||||
| Pyrexia | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Infections and infestations | ||||||||||||||||||||||||||||||||||||||
| Nasopharyngitis | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||||||||||
| Arthropod bite | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Wound | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||||||||||||
| Arthralgia | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Back pain | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 2/6 (33.3%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Pain in extremity | 1/16 (6.3%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||||||||||||||||
| Ageusia | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Dizziness | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/10 (10%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Dizziness postural | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Headache | 3/16 (18.8%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 3/6 (50%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 2/6 (33.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Hypersomnia | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Hypoaesthesia | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Paraesthesia | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Parosmia | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Poor quality sleep | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Presyncope | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Somnolence | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 2/14 (14.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Taste disorder | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Psychiatric disorders | ||||||||||||||||||||||||||||||||||||||
| Abnormal dreams | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Insomnia | 0/16 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | |||||||||||||||||||
| Renal and urinary disorders | ||||||||||||||||||||||||||||||||||||||
| Chromaturia | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | |||||||||||||||||||
| Pollakiuria | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||||||||||||||||||||
| Vaginal haemorrhage | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/10 (10%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||||||||
| Cough | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Epistaxis | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Oropharyngeal pain | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Rhinorrhoea | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||||||||
| Acne | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Pruritus | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | |||||||||||||||||||
| Rash | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | |||||||||||||||||||
| Scab | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 1/10 (10%) | 0/14 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
| Vascular disorders | ||||||||||||||||||||||||||||||||||||||
| Hot flush | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/10 (0%) | 0/10 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PI is required to obtain written consent from the Sponsor before anything relating to the study can be published.
Results Point of Contact
| Name/Title | Dr. Wendy Painter |
|---|---|
| Organization | Ridgeback Biotherapeutics |
| Phone | 786-687-2495 |
| EIDD2801@ridgebackbio.com |
Responsible Party:
Ridgeback Biotherapeutics, LP
ClinicalTrials.gov Identifier:
NCT04392219
Other Study ID Numbers:
- EIDD-2801-1001
- 2020-001407-17
First Posted:
May 18, 2020
Last Update Posted:
Jul 19, 2021
Last Verified:
Jul 1, 2021