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
Overview
- Phase
- Phase 1
- Intervention
- EIDD-2801
- Conditions
- Coronavirus
- Sponsor
- Ridgeback Biotherapeutics, LP
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a First In Human study designed to assess the safety, tolerability and pharmacokinetics of EIDD-2801 in healthy human volunteers.
Detailed Description
This is a randomized, double-blind, placebo-controlled, First-in-Human study designed to evaluate the safety, tolerability, and pharmacokinetics of EIDD-2801 following oral administration to healthy volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female between the ages of 18 and 60, inclusive.
- •Female participants must be of non-childbearing potential.
- •Male participants must agree to the use of effective contraception for study duration
- •Is in generally good health as determined by medical history, physical examinations (PEs) (at Screening and/or Check-in), vital signs, and other screening procedures.
- •Has a body mass index (BMI) of 18 to 30 kg/m\^2.
Exclusion Criteria
- •Females who are pregnant, planning to become pregnant, or breastfeeding.
- •Has a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal (GI), hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as determined by the principal investigator (PI) (or designee).
- •Has any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
- •Has a history of cancer (other than basal cell or squamous cell cancer of the skin), rheumatologic disease or blood dyscrasias.
- •Has a history of gastrointestinal (GI) surgery or other condition that may interfere with absorption of study drug, in the opinion of the principal investigator (PI) (or designee).
- •Has a history of febrile illness within the 14 days prior to the first dose of study drug.
- •Has a positive alcohol or drug screen at Screening or the Day -1 visit or has a history of alcohol or drug abuse within the past 5 years.
- •Currently uses tobacco, nicotine or tobacco products or e-cigarettes, or stopped using tobacco products within the past 3 months
- •Has a total white cell count or absolute lymphocyte count outside the normal range, or hemoglobin or platelet levels below the lower limit of normal, at Screening or Day -
- •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 -
Arms & Interventions
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.
Intervention: EIDD-2801
Placebo
Placebo: Part 1: Participants were randomized to receive placebo (fasted); Part 3: Participants were randomized to receive placebo (fasted).
Intervention: Placebo
Outcomes
Primary Outcomes
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
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