Evaluation of EDP-938 in subjects aged 28 days to 36 months infected with respiratory syncytial virus (RSV)

Phase 1

• Conditions: Respiratory Syncytial Virus (RSV); MedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001966-13-PL
• Lead Sponsor: Enanta Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-26
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Male or female who is either:
• born =37 weeks of gestation and is age =28 days to =36months, defined at the time of randomization, or
• born <37 weeks of gestation and is age =6 months to =36 months, defined at the time of randomization
2. Subjects diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection by another respiratory pathogen (respiratory virus, fungus, or bacteria), except in cases where the Investigator assesses that a co-detection of the following viruses is not contributing to the patient's disease: human bocavirus, rhinovirus, or rhinovirus/enterovirus;
3. Subjects with signs of an acute respiratory illness (eg, fever [or symptoms of fever], cough, nasal congestion, runny nose, rapid breathing, shortness of breath, or wheezing) with onset =7 days before the time of signing the informed consent form (ICF)
Note: Time of onset of symptoms is defined from the caregiver(s) estimated time of awareness of the first sign of respiratory infection
4. Have a calculated creatinine clearance rate not below the lower limit of normal (LLN) for the subject’s age as determined by the Schwartz equation (Schwartz & Work, 2009) at Screening
5. In the Investigator’s opinion, the subject’s caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned

Additional inclusion criterion for Part 1 Cohort 1
6. Subject is currently or is planned to be hospitalized as a consequence of RSV infection and is not anticipated to be discharged in less than 24 hours after enrollment
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Use of or anticipated need for intensive monitoring and associated medical care, eg admission to ICU or equivalent medical setting, requirement for mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
2. Subjects who have a medical history or a concurrent illness that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments. Examples include liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic conditions
3. Subjects who are considered unable to take study drug orally, eg, as a consequence of acute respiratory distress, or unable to absorb study drug enterally
4. Subjects who have received blood products within 6 months of study drug administration
5. Height or weight outside of the 5th to 95th percentile for the respective ages, at the time of enrollment
6. Subjects with underlying immune deficiency, eg, from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency
7. Subjects who received (within 12 months before Screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
8. Subjects who have had major surgery in the 6 weeks before randomization
9. Subject receiving chronic oxygen therapy at home before admission
10. Subjects who are being breastfed by a mother taking any of the excluded medications
11. Subjects whose mother received an investigational RSV vaccination while pregnant with the subject
12. Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days of Screening
13. Subjects who received systemic medications (either chronically [more than 14 days] or within 21 days before randomization) that are known to modulate the host’s immune response or increase viral shedding, such as immunomodulatory therapies
14. Subjects who are receiving an investigational or approved medication that is intended to prevent or treat RSV infection (eg, ribavirin or palivizumab or other RSV specific monoclonal antibody) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug, and/or is currently enrolled in a clinical trial of such a medication
15. Use of or intention to use any medication or supplement known to be a moderate or strong inducer or inhibitor of the cytochrome P450 3A4 enzyme within 14 days before the first dose of study drug
16. Subjects who are enrolled in another investigational drug or vaccine study
17. Known allergy/hypersensitivity or intolerance to EDP-938 placebo or their excipients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Part 1<br>•To evaluate the PK of EDP-938 <br>•To assess the safety and tolerability of EDP-938 <br>Part 2<br>•To evaluate the antiviral activity of EDP-938 ;Secondary Objective: Part 1<br>•To evaluate the antiviral activity of EDP-938 <br>Part 2<br>•To assess the safety and tolerability of EDP-938<br>•To evaluate the PK of EDP-938 ;Primary end point(s): Part 1<br>1) PK parameters of EDP-938 including area under the curve (AUC) and predose concentrations<br>2) Safety and tolerability of EDP-938 compared to placebo as assessed by, but not limited to, AEs, vital signs, and clinical laboratory results<br><br>Part 2<br>1) Daily change in RSV shedding in nasal swab samples determined using quantitative RT-PCR from before the first dose of study drug (Baseline) through treatment phase;Timepoint(s) of evaluation of this end point: Part 1<br>1) From Day 1 up to 10 hours post Day 5 dose<br>2) From baseline up to Day 28<br><br>Part 2<br>1) From baseline up to Day 14