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A Study of EDP-235 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05246878
Recruitment Status : Completed
First Posted : February 18, 2022
Last Update Posted : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals, Inc

Study Description
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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
SARS CoV 2 Infection Drug: EDP-235 Drug: Placebo 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First In Human Study of Orally Administered EDP-235 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-235 Pharmacokinetics in Healthy Participants
Actual Study Start Date : January 28, 2022
Actual Primary Completion Date : July 20, 2022
Actual Study Completion Date : July 20, 2022
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Safety measured by adverse events [ Time Frame: Up to 8 Days in HV SAD Cohorts ]
  2. Safety measured by adverse events [ Time Frame: Up to 14 Days in HV MAD Cohorts ]

Secondary Outcome Measures :
  1. Cmax of EDP-235 [ Time Frame: Up to 5 Days in HV SAD Cohorts ]
  2. AUC of EDP-235 [ Time Frame: Up to 5 Days in HV SAD Cohorts ]
  3. Cmax of EDP-235 [ Time Frame: Up to 11 Days in HV MAD Cohorts ]
  4. AUC of EDP-235 [ Time Frame: Up to 11 Days in HV MAD Cohorts ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05246878


Locations
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United States, Kansas
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Enanta Pharmaceuticals, Inc
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
More Information
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Responsible Party: Enanta Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT05246878    
Other Study ID Numbers: EDP 235-001
First Posted: February 18, 2022    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enanta Pharmaceuticals, Inc:
First-in-Human
Single Ascending Dose
Multiple Ascending Dose
Healthy Volunteer
COVID-19
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases