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OpenTrials
Completed

NCT Number: NCT05587478

A Study of EDP-323 in Healthy Subjects

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.

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Key information

Conditions

RSV Infection Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON, plc.

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EDP-323

Drug

Oral administration

Placebo

Drug

Placebo to match EDP-323, oral administration

Primary outcomes

  1. Safety measured by adverse events

    Time frame: Up to 8 Days in SAD Cohorts

  2. Safety measured by adverse events

    Time frame: Up to 14 Days in MAD Cohorts

Secondary outcomes

  1. Cmax of EDP-323

    Time frame: Up to 5 Days in SAD Cohorts

  2. AUC of EDP-323

    Time frame: Up to 5 Days in SAD Cohorts

  3. Cmax of EDP-323

    Time frame: Up to 11 Days in MAD Cohorts

  4. AUC of EDP-323

    Time frame: Up to 11 Days in MAD Cohorts

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Registry information

Official study title

A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In- Human Study of Orally Administered EDP-323 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-323 Pharmacokinetics in Healthy Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2022
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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