A Study of EDP-235 in Healthy Subjects
Study Details
Study Description
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 adult subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 ascending doses of EDP-235 or placebo for 7-days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-235 or placebo.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EDP-235 SAD Cohorts EDP-235 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5, orally, once daily in one single administration |
Drug: EDP-235
Oral administration
|
| Experimental: EDP-235 MAD Cohorts EDP-235 Dose 1, Dose 2 and Dose 3 orally, once daily for 7 days |
Drug: EDP-235
Oral administration
|
| Placebo Comparator: EDP-235 SAD Placebo Cohorts Matching placebo, orally, once daily in one single administration |
Drug: Placebo
Placebo to match EDP-235, oral administration
|
| Placebo Comparator: EDP-235 MAD Placebo Cohorts Matching placebo, orally, once daily for 7 days |
Drug: Placebo
Placebo to match EDP-235, oral administration
|
Outcome Measures
Primary Outcome Measures
- Safety measured by adverse events [Up to 8 Days in HV SAD Cohorts]
- Safety measured by adverse events [Up to 14 Days in HV MAD Cohorts]
Secondary Outcome Measures
- Cmax of EDP-235 [Up to 5 Days in HV SAD Cohorts]
- AUC of EDP-235 [Up to 5 Days in HV SAD Cohorts]
- Cmax of EDP-235 [Up to 11 Days in HV MAD Cohorts]
- AUC of EDP-235 [Up to 11 Days in HV MAD Cohorts]
Eligibility Criteria
Criteria
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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pharmaceutical Research Associates, Inc., | Lenexa | Kansas | United States | 66219 |
Sponsors and Collaborators
- Enanta Pharmaceuticals
Investigators
- Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EDP 235-001