A Study of EDP-235 in Healthy Subjects

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: SARS CoV 2 Infection

Treatments: Drug: EDP-235; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05246878

EDP 235-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

EDP-235 SAD Cohorts

Experimental group

Description:

EDP-235 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5, orally, once daily in one single administration

Treatment:

Drug: EDP-235

EDP-235 MAD Cohorts

Experimental group

Description:

EDP-235 Dose 1, Dose 2 and Dose 3 orally, once daily for 7 days

Treatment:

Drug: EDP-235

EDP-235 SAD Placebo Cohorts

Placebo Comparator group

Description:

Matching placebo, orally, once daily in one single administration

Treatment:

Drug: Placebo

EDP-235 MAD Placebo Cohorts

Placebo Comparator group

Description:

Matching placebo, orally, once daily for 7 days

Treatment:

Drug: Placebo