RSV Infection
Conditions
Keywords
First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Healthy Volunteer
Brief summary
This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects.
Interventions
DRUGEDP-323
Oral administration
DRUGPlacebo
Placebo to match EDP-323, oral administration
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* An informed consent document signed and dated by the subject. * Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.
Exclusion criteria
* Clinically relevant evidence or history of illness or disease. * Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit * Pregnant or nursing females. * History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * A positive urine drug screen at screening or Day -1. * Current tobacco smokers or use of tobacco within 3 months prior to screening. * Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * History of regular alcohol consumption. * Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 8 Days in SAD Cohorts |
Secondary
| Measure | Time frame |
|---|---|
| Cmax of EDP-323 | Up to 5 Days in SAD Cohorts |
| AUC of EDP-323 | Up to 5 Days in SAD Cohorts |
Countries
United States
Outcome results
None listed