Trial reportClinical and translational science2025
EDP-323, a First-In-Class, Once-Daily, Oral L-Protein Inhibitor for the Treatment of RSV: Results From a Phase 1 Study in Healthy Adults.
Trial report in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- Phase 2a Randomized Placebo-Controlled Human Challenge Trial of the Respiratory Syncytial Virus L-Protein Inhibitor S-337395 for Respiratory Syncytial Virus Infection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Observational
- Utilizing Virtual Clinical Trials to Inform Target Coverage That Drives RSV Antiviral Efficacy.CPT: pharmacometrics & systems pharmacology · 2026Article
- Targeting the RSV and hMPV L Protein: Cryo-EM and Structure-Based Approaches to Antiviral Drug Discovery.Biomolecules · 2026Review
- Catching our breath: development of interventions and therapies for respiratory syncytial virus.Microbiology and molecular biology reviews : MMBR · 2026Review
- Small Molecule Inhibition of Mononegavirales RNA Polymerases.Journal of medical virology · 2026Review
- Structural Mapping of Surveillance Data Reveals Conservation of NNI Binding Site in RSV L Protein.Pathogens (Basel, Switzerland) · 2026Article
- Respiratory syncytial virus (RSV) antibody and small-molecule drugs: current status of clinical translation and challenges.Frontiers in microbiology · 2026Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Respiratory syncytial virus (RSV) remains a significant health concern, particularly for vulnerable populations. Despite preventive strategies, there remains a need for effective antiviral treatments. EDP-323 is a first-in-class, potent oral selective non-nucleoside inhibitor of the large protein (L polymerase) of RSV under investigation for the treatment of RSV infection. This phase 1, randomized, double-blind, placebo-controlled study evaluated the safety and pharmacokinetics of EDP-323. This study included fasted single ascending dose (SAD; EDP-323 50/100/200/400/600/800 mg doses, 3:1 to placebo), fed multiple ascending dose (MAD; EDP-323200/400/600/800 mg doses, 3:1 to placebo), and food effect (EDP-323200 mg dose, 4:1 to placebo) cohorts in healthy adult participants. Key objectives were to assess the safety, tolerability, and pharmacokinetic (PK) profile of EDP-323 in plasma and urine, and to evaluate the effect of food intake on its pharmacokinetics. Among 82 randomized participants (SAD, n = 50; MAD, n = 32), EDP-323 was well tolerated up to the highest tested dose (800 mg once daily for 7 days). Adverse events (AEs) were reported in 14.6% of total participants, with the majority being mild and deemed unlikely related to the study drug. Headache was the most frequent AE (n = 3). PK analysis showed that EDP-323 was rapidly absorbed (T
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