A Study of EDP-235 in Healthy Subjects

NCT05246878 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 235-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS CoV 2 Infection

Keywords

First-in-Human; Single Ascending Dose; Multiple Ascending Dose; Healthy Volunteer; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (4)

EDP-235 SAD Cohorts

EXPERIMENTAL

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

Drug: EDP-235

EDP-235 MAD Cohorts

EXPERIMENTAL

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

Drug: EDP-235

EDP-235 SAD Placebo Cohorts

PLACEBO COMPARATOR

Matching placebo, orally, once daily in one single administration

Drug: Placebo

EDP-235 MAD Placebo Cohorts

PLACEBO COMPARATOR

Matching placebo, orally, once daily for 7 days

Drug: Placebo

Interventions

EDP-235 DRUG

Oral administration

EDP-235 MAD Cohorts; EDP-235 SAD Cohorts

Placebo DRUG

Placebo to match EDP-235, oral administration

EDP-235 MAD Placebo Cohorts; EDP-235 SAD Placebo Cohorts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

EDP-235

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: January 28, 2022
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)