A Study of EDP-323 in Healthy Subjects

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: RSV Infection

Treatments: Drug: Placebo; Drug: EDP-323

Study type: Interventional

Funder types: Industry

Identifiers

NCT05587478

EDP 323-001

Details and patient eligibility

About

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.

Enrollment: 82 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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82 participants in 4 patient groups, including a placebo group

EDP-323 SAD Cohorts

Experimental group

Description:

EDP-323 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, orally, once daily in one single administration

Treatment:

Drug: EDP-323

EDP-323 MAD Cohorts

Experimental group

Description:

EDP-323 Dose 1, Dose 2, Dose 3 and Dose 4 orally, once daily for 7 days

Treatment:

Drug: EDP-323

EDP-323 SAD Placebo Cohorts

Placebo Comparator group

Description:

Matching placebo, orally, once daily in one single administration

Treatment:

Drug: Placebo

EDP-323 MAD Placebo Cohorts

Placebo Comparator group

Description:

Matching placebo, orally, once daily for 7 days

Treatment:

Drug: Placebo