Trial reportAdvances in therapy2026
Safety, Tolerability and PK Characteristics of RM301B Eye Drops: A Single-Centre, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
12 authors.
Funding
Abstract
introductionRM301B eye drops are a dexamethasone (DEX)-based formulation indicated for treating macular oedema associated with retinal vein occlusion (RVO). Non-clinical pharmacodynamic studies have demonstrated that RM301B eye drops have a certain inhibitory effect on retinal oedema. This study aimed to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of RM301B eye drops following administration in healthy subjects.
methodsA single-centre, randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical study. In the single-dose study, ten subjects received once-daily RM301B or placebo. In the multiple ascending dose study, 30 subjects received 3, 6, or 8 daily instillations for 7 days. Safety and tolerability were monitored throughout the study, with plasma samples collected for PK analysis.
resultsNo serious adverse events (SAEs) occurred in the study. All mild adverse events (AEs) were determined to be unrelated to RM301B. PK results indicated detectable plasma concentrations (0.10-0.40 ng/ml) only in individual subjects within 5 h post-single dose and at specific time points following multiple dosing. Mean area under the curve from time zero to t (AUC
conclusionsRM301B eye drops demonstrated safety and good tolerability in subjects, characterized by minimal plasma exposure, a short half-life, and no significant accumulation. Subsequent trials will evaluate the safety and efficacy of RM301B in patients with macular oedema associated with RVO.
trial registrationChiCTR2500111837 (retrospectively registered on November 6, 2025).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.