Status:
COMPLETED
A Study of EDP-235 in Healthy Subjects
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Conditions:
SARS CoV 2 Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-235 in healthy...
Detailed Description
The first phase assesses single ascending doses of EDP-235 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect. The second phase assesses multiple ascend...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05246878
Start Date
January 28 2022
End Date
July 20 2022
Last Update
August 19 2022
Active Locations (1)
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1
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States, 66219