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

NCT04392219 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: EIDD-2801-10012020-001407-17
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronavirus

Keywords

Coronavirus; EIDD-2801; ribonucleoside

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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).

Drug: Placebo

Interventions

EIDD-2801 DRUG

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.

Also known as: Molnupiravir

EIDD-2801

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ridgeback Biotherapeutics, LP: lead

Study Sites (1)

Covance Leeds Clinical Research Unit

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

molnupiravir

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Dr. Wendy Painter
• Organization: Ridgeback Biotherapeutics

EIDD2801@ridgebackbio.com

786-687-2495

Study Officials

• Jim Bush, MBChB, PhD

  Covance Clinical Research Unit Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 18, 2020
• Study Start: April 10, 2020
• Primary Completion: August 11, 2020
• Study Completion: August 11, 2020
• Last Updated: July 19, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)