CoronavirusPhase 1NCT04392219

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

A Phase 1 study testing EIDD-2801 in people with Coronavirus, run by Ridgeback Biotherapeutics, LP at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Coronavirus
What is being tested?: EIDD-2801
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 1 siteUnited Kingdom
Study dates: 10 Apr 2020to 11 Aug 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 20Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Leeds Clinical Research Unit
Leeds

Other trials in United Kingdom

About this study

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

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

Read the 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.

Conditions: Coronavirus
Being tested: EIDD-2801, Placebo
Keywords: Coronavirus, EIDD-2801, ribonucleoside
Medical subject headings: Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EIDD-2801Drug
Also called Molnupiravir
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.
PlaceboDrug
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.

Study groups in NCT04392219
Study group	Role	What they receive
EIDD-2801	Experimental	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. Receives: Drug: EIDD-2801
Placebo	Placebo comparator	Placebo: Part 1: Participants were randomized to receive placebo (fasted); Part 3: Participants were randomized to receive placebo (fasted). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: From screening through study completion, up to 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 202011 Aug 2020

First posted18 May 2020
Study start10 Apr 2020
Primary completion11 Aug 2020
Study completion11 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CoronavirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04392219
Sponsor's protocol ID: EIDD-2801-1001
Other IDs: 2020-001407-17
Status last verified: Jul 2021
First submitted: 29 Apr 2020
Last updated: 19 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04392219
Acronym / sponsor ID: EIDD-2801-1001
Conditions: Coronavirus
Keywords: Coronavirus, EIDD-2801, ribonucleoside
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Ridgeback Biotherapeutics, LPIndustry (pharma, biotech, devices)
Study start: 10 Apr 2020 (actual)
Primary completion: 11 Aug 2020 (actual)
Study completion: 11 Aug 2020 (actual)
First posted: 18 May 2020 (actual)
Results: Posted 19 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
EIDD-2801	Experimental	Drug: EIDD-2801EIDD-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.
Placebo	Placebo comparator	Drug: PlaceboPlacebo: Part 1: Participants were randomized to receive placebo (fasted); Part 3: Participants were randomized to receive placebo (fasted).

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (20 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EIDD-2801Also: MolnupiravirPart 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	EIDD-2801
PlaceboPart 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.	Drug	Placebo

Primary outcome

Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 19 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 - Placebo	16	16
Part 1 - 50 mg EIDD-2801	6	6
Part 1 - 100 mg EIDD-2801	6	6
Part 1 - 200 mg EIDD-2801	6	6
Part 1 - 400 mg EIDD-2801	6	6
Part 1 - 600 mg EIDD-2801	6	6
Part 1 - 800 mg EIDD-2801	6	6
Part 1 - 1200 mg EIDD-2801	6	6
Part 1 - 1600 mg EIDD-2801	6	6
Part 2 - 200 mg EIDD-2801 (Fasted/Fed)	10	10
Part 3 - Placebo	14	14
Part 3 - 50 mg EIDD-2801	6	6
Part 3 - 100 mg EIDD-2801	6	6
Part 3 - 200 mg EIDD-2801	6	6
Part 3 - 300 mg EIDD-2801	6	6
Part 3 - 400 mg EIDD-2801	6	6
Part 3 - 600 mg EIDD-2801	6	6
Part 3 - 800 mg EIDD-2801	6	6

Primary outcome: Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events

Time frame: From screening through study completion, up to 15 days. Count of participants. Unit: Participants

Measure	Part 1 - Placebo n = 16	Part 1 - 50 mg EIDD-2801 n = 6	Part 1 - 200 mg EIDD-2801 n = 6	Part 1 - 400 mg EIDD-2801 n = 6	Part 1 - 600 mg EIDD-2801 n = 6	Part 1 - 800 mg EIDD-2801 n = 6	Part 1 - 1200 mg EIDD-2801 n = 6	Part 1 - 1600 mg EIDD-2801 n = 6
TEAEs (Overall)	7	2	3	3	4	2	1	2
Mild (Grade 1)	7	2	3	3	4	2	1	2
Moderate (Grade 2)	1	0	0	1	0	0	0	0
Severe (Grade 3)	0	0	0	0	0	0	0	0

Population analysed: Safety population

Primary outcome: Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events

Time frame: From screening through study completion, up to 20 days. Count of participants. Unit: Participants

Measure	Part 3 - Placebo n = 14	Part 3 - 50 mg EIDD-2801 n = 6	Part 3 - 100 mg EIDD-2801 n = 6	Part 3 - 200 mg EIDD-2801 n = 6	Part 3 - 300 mg EIDD-2801 n = 6	Part 3 - 400 mg EIDD-2801 n = 6	Part 3 - 600 mg EIDD-2801 n = 6	Part 3 - 800 mg EIDD-2801 n = 6
TEAEs (Overall)	7	2	3	3	2	3	2	3
Mild (Grade 1)	7	2	3	3	2	3	2	3
Moderate (Grade 2)	0	0	0	1	0	0	0	0
Severe (Grade 3)	0	0	0	0	0	0	0	0

Population analysed: Safety population

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). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 - Placebo	0 of 16 (0%)	7 of 16 (43.8%)	0 of 16
Part 1 - 50 mg EIDD-2801	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 1 - 100 mg EIDD-2801	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part 1 - 200 mg EIDD-2801	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 1 - 400 mg EIDD-2801	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 1 - 600 mg EIDD-2801	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part 1 - 800 mg EIDD-2801	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 1 - 1200 mg EIDD-2801	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part 1 - 1600 mg EIDD-2801	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 2 - 200 mg EIDD-2801 (Fasted)	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Part 2 - 200 mg EIDD-2801 (Fed)	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Part 3 - Placebo	0 of 14 (0%)	7 of 14 (50%)	0 of 14
Part 3 - 50 mg EIDD-2801	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 3 - 100 mg EIDD-2801	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 3 - 200 mg EIDD-2801	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 3 - 300 mg EIDD-2801	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 3 - 400 mg EIDD-2801	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 3 - 600 mg EIDD-2801	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 3 - 800 mg EIDD-2801

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jim Bush, MBChB, PhD principal investigator

Covance Clinical Research Unit Limited

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EIDD-2801 in people with Coronavirus, run by Ridgeback Biotherapeutics, LP at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events (time frame: From screening through study completion, up to 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04392219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.