NCT06170242
Completed
Phase 2
A Randomized, Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy Adults
ConditionsRSV Infection
Overview
- Phase
- Phase 2
- Intervention
- EDP-323 Dose Regimen 1
- Conditions
- RSV Infection
- Sponsor
- Enanta Pharmaceuticals, Inc
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR): RSV Area Under the Viral Load-time Curve (VL-AUC)
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
A randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-323 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to assess the antiviral effect of EDP-323 compared to a placebo control in the respiratory syncytial virus challenge model.
Investigators
Eligibility Criteria
Inclusion Criteria
- •An informed consent document signed and dated by the subject.
- •Age 18 to 55 years, inclusive.
- •In good health with no history of major medical conditions.
- •A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 35kg/m2.
Exclusion Criteria
- •Pregnant or nursing females
- •Acute or chronic medical illness
- •History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit.
- •Abnormal lung function
- •Positive for HIV, active hepatitis B or C test
- •Nose or nasopharynx abnormalities
- •Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug
Arms & Interventions
EDP-323 Arm A
Subjects will take EDP-323 Dose 1 orally for 5 days
Intervention: EDP-323 Dose Regimen 1
EDP-323 Arm B
Subjects will take EDP-323 Dose 2 orally for 5 days
Intervention: EDP-323 Dose Regimen 2
Placebo Arm C
Subjects will take matching placebo orally for 5 days
Intervention: Placebo
Outcomes
Primary Outcomes
Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR): RSV Area Under the Viral Load-time Curve (VL-AUC)
Time Frame: Day 1 to Day 12
Measured by qRT-PCR in nasal samples.
Secondary Outcomes
- qRT-PCR: RSV Peak Viral Load (VLPEAK)(Day 1 to Day 12)
- qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK(Day 1 to Day 12)
- qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity(Day 1 to Day 12)
- qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to First Negative Slope of RSV Viral Load(Day 1 to Day 12)
- qRT-PCR: RSV Viral Load Clearance Rate - EDP-323 High Dose(Up to Day 16)
- qRT-PCR: RSV Viral Load Clearance Rate - EDP-323 Low Dose(Up to Day 16)
- Viral Culture: RSV VL-AUC(Day 1 to Day 12)
- Viral Culture: RSV VLPEAK(Day 1 to Day 12)
- Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK(Day 1 to Day 12)
- Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity(Day 1 to Day 12)
- Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to First Negative Slope of RSV Viral Load(Day 1 to Day 12)
- Viral Culture: RSV Viral Load Clearance Rate(Up to Day 16)
- Area Under the Total Symptom Score (TSS)-Time Curve (TSS-AUC)(Day 1 to Day 12)
- Peak TSS(Day 1 to Day 12)
- Time to Peak TSS(Day 1 to Day 12)
- Time to Resolution From Peak TSS(Day 1 to Day 12)
- Total Weight of Nasal Discharge (Mucus) Produced(Day 1 to Day 12)
- Total Number of Tissues Used(Day 1 to Day 12)
- Maximum Plasma Concentration (Cmax)(First Dose: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose) and Day 2 pre-dose; Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose))
- Time to Cmax (Tmax)(First Dose: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose) and Day 2 pre-dose; Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose))
- Terminal Half-life (t1/2)(Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose))
- Apparent Systemic Clearance at Steady-state (CLss/F)(Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose))
- Terminal Elimination Rate Constant (λz)(Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose))
- Apparent Volume of Distribution at Steady-state (Vss/F)(Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose))
- Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h)(First Dose: Day 1, 12 and 24 hours post-dose; Last Dose: Day 5, 12 and 24 hours post-dose)
- Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)(First Dose: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose) and Day 2 pre-dose; Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose))
- Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau)(Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose))
- Number of Participants With Adverse Events (AEs) up to Discharge(Day -2 to Day 12)
- Number of Participants With Treatment-emergent Adverse Events(Day 1 to Day 28)
Study Sites (1)
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