Phase 2
Completed N=142
A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model
RSV Infection
Source: ClinicalTrials.gov NCT06170242 ↗
Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR): RSV Area Under the Viral Load-time Curve (VL-AUC) — 99.05; 82.28; 657.45 log10 copies/mL*hours — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR): RSV Area Under the Viral Load-time Curve (VL-AUC) |
99.05; 82.28; 657.45 | <0.0001 sig |
| SECONDARY qRT-PCR: RSV Peak Viral Load (VLPEAK) |
2.52; 1.99; 6.48 | <0.0001 sig |
| SECONDARY qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK |
2.89; 3.12; 3.12 | 0.6330 |
| SECONDARY qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity |
2.3; 1.5; 8.5 | — |
| SECONDARY qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to First Negative Slope of RSV Viral Load |
0.77; 1.33; 2.60 | 0.0021 sig |
| SECONDARY qRT-PCR: RSV Viral Load Clearance Rate - EDP-323 High Dose |
-0.5650; -1.3299 | — |
| SECONDARY qRT-PCR: RSV Viral Load Clearance Rate - EDP-323 Low Dose |
-0.5480; -1.3298 | — |
| SECONDARY Viral Culture: RSV VL-AUC |
3.82; 6.21; 227.04 | <0.0001 sig |
| SECONDARY Viral Culture: RSV VLPEAK |
0.04; 0.16; 3.45 | <0.0001 sig |
| SECONDARY Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK |
5.82; 5.78; 3.95 | 0.0238 sig |
| SECONDARY Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity |
0.5; 0.5; 4.5 | — |
| SECONDARY Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to First Negative Slope of RSV Viral Load |
0.00; 0.00; 2.92 | 0.0389 sig |
| SECONDARY Viral Culture: RSV Viral Load Clearance Rate |
-0.1336; -0.2565; -1.1124 | — |
| SECONDARY Area Under the Total Symptom Score (TSS)-Time Curve (TSS-AUC) |
127.31; 82.67; 369.10 | <0.0001 sig |
| SECONDARY Peak TSS |
2.65; 2.35; 5.77 | <0.0001 sig |
| SECONDARY Time to Peak TSS |
2.00; 2.84; 3.36 | 0.0552 |
| SECONDARY Time to Resolution From Peak TSS |
2.16; 2.58; 2.93 | 0.0307 sig |
| SECONDARY Total Weight of Nasal Discharge (Mucus) Produced |
6.12; 9.49; 16.44 | 0.0042 sig |
| SECONDARY Total Number of Tissues Used |
17.62; 16.22; 28.79 | 0.0026 sig |
| SECONDARY Maximum Plasma Concentration (Cmax) |
1358.47; 1453.70; 1703.09; 759.38; 1225.02; 1501.55 | — |
| SECONDARY Time to Cmax (Tmax) |
3.98; 3.92; 4.82; 4.10; 3.97; 3.85 | — |
| SECONDARY Terminal Half-life (t1/2) |
13.07; 12.55; 16.56; 17.16; 3.89 | — |
| SECONDARY Apparent Systemic Clearance at Steady-state (CLss/F) |
32.39; 24.51 | — |
| SECONDARY Terminal Elimination Rate Constant (λz) |
0.06; 0.06; 0.04; 0.04; 0.17 | — |
| SECONDARY Apparent Volume of Distribution at Steady-state (Vss/F) |
569.26; 402.73 | — |
| SECONDARY Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h) |
711.96; 756.02; 351.45; 368.54; 935.04; 423.38 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) |
15626.46; 16703.77; 31084.37; 13816.76; 7181.42; 8319.19 | — |
| SECONDARY Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau) |
21585.30; 9653.80; 8944.82; 2588.19; 48.21; 7.31 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) up to Discharge |
13; 15; 15; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
11; 14; 13; 0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT06170242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.