Phase 2
Completed N=178
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
RSV Infection
Source: ClinicalTrials.gov NCT03691623 ↗
Enrolled (actual)
178
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load — 134.70; 113.51; 624.30; 80.61 hours*log10 copies/milliliter (mL) — p=< 0.001
Summary
A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load |
134.70; 113.51; 624.30; 80.61; 160.81; 808.28 | < 0.001 sig |
| SECONDARY Area Under the Curve (AUC) of Total Symptom Score |
61.18; 37.36; 252.49; 26.70; 27.81; 232.53 | < 0.001 sig |
| SECONDARY Peak Total Symptom Score |
2.3; 1.9; 4.9; 1.6; 1.8; 4.2 | < 0.001 sig |
| SECONDARY Total Symptom Score |
0.9; 0.8; 1.9; 0.5; 0.3; 3.0 | — |
| SECONDARY Time to Peak Total Symptom Score |
1.18; 1.76; 2.15; 1.45; 1.09; 1.94 | = 0.199 |
| SECONDARY Time to Resolution From Peak Total Symptom Score |
2.49; 2.83; 3.30; 2.19; 1.38; 5.17 | = 0.145 |
| SECONDARY Total Weight of Nasal Mucus Produced |
12.965; 7.428; 33.416; 2.983; 4.716; 22.391 | < 0.001 sig |
| SECONDARY Peak Viral Load |
4.3552; 4.3111; 6.4727; 3.9718; 4.7727; 7.0973 | < 0.001 sig |
| SECONDARY Time to Peak Viral Load |
0.74; 0.80; 2.59; 0.88; 0.79; 3.43 | < 0.001 sig |
| SECONDARY Time to Resolution From Peak Viral Load |
2.03; 2.02; 4.03; 1.67; 1.63; 3.58 | < 0.001 sig |
| SECONDARY Time to Cessation of Virus Detection |
3.5; 3.2; 8.5; 2.7; 2.5; 8.5 | < 0.001 sig |
| SECONDARY Safety and Tolerability as Assessed by Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
20; 21; 21; 8; 10; 11 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites |
1370; 1151; 1237.91; 800.73; 1740; 1480 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites |
4.56; 5.00; 5.80; 6.07; 4.52; 4.10 | — |
| SECONDARY Terminal Phase Half-Life (t1/2) of EDP-938 and Its Metabolites |
14.5; 13.8; 14.5; 13.7; 14.5; 13.4 | — |
| SECONDARY Apparent Systemic Clearance at Steady State (CLss/F) of EDP-938 |
26.9; 24.1; 21.3; 25.0 | — |
| SECONDARY Terminal Phase Rate Constant Calculated by Linear Regression of the Terminal Loglinear Portion of the Concentration vs. Time Curve (λz) of EDP-938 and Its Metabolites |
0.05; 0.05; 0.05; 0.05; 0.05; 0.05 | — |
| SECONDARY Volume of Distribution at Steady State (Vss/F) of EDP-938 |
560; 476; 442; 491 | — |
| SECONDARY Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites |
679.35; 565.60; 822; 525; 168; 149 | — |
| SECONDARY Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites |
404; 453; 491; 287; 121; 136 | — |
| SECONDARY Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites |
16730; 7540; 16420; 5970; 32000; 27300 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of EDP-938 and Its Metabolites |
22300; 12500; 14100; 8010; 5770; 3270 | — |
| SECONDARY Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Viral Load AUC |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Total Symptom Score (TSS) AUC |
0; 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/m^2 and ≤ 30kg/m^2
Exclusion Criteria
- Pregnant or nursing females
- Acute or chronic medical illness
- Abnormal lung function
- Positive for human immunodeficiency virus (HIV), active hepatitis A, 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 (NCT03691623). 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.