Trial reportDrug design, development and therapy2026
Safety and Pharmacokinetics of SRN001, a Novel siRNA Drug Targeting Amphiregulin via the SAMiRNA Platform.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05984992 (A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of SRN-001 in Healthy Participants), which is not on this map. Not yet cited in PubMed.
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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.
A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of SRN-001 in Healthy Participants
Who cites it
0 citing papers in PubMed.
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: SRN001 is a small interfering RNA (siRNA) drug targeting amphiregulin. It was developed using a novel SAMiRNA Methods: A randomized, double-blind, placebo-controlled, single ascending dose, Phase 1 trial was conducted (NCT05984992). Participants randomly received a single intravenous dose of SRN001 (15, 45, 135, or 210 mg) or placebo. Safety was assessed with vital signs, clinical laboratory tests, electrocardiograms, and inflammatory cytokine assays (IL-1β, IL-6, IFN-γ, and TNF-α). Serial blood samples were collected until 168 hours post-dose to quantify plasma antisense siRNA concentrations. Anti-drug antibodies (ADAs) were measured at pre-dose, 15 days, and 29 days post-dose. Results: Among 25 participants, SRN001 was generally well tolerated. Unlike other approved siRNA drugs, no systemic symptoms or cytokine elevation suggestive of infusion-related reactions (IRRs) were observed in any subjects receiving SRN001, even without premedication. SRN001 exhibited dose-proportional exposure, with the average AUC Conclusion: A single IV administration of SRN001 demonstrated a favorable safety profile and dose-proportional PK in this small first-in-human phase 1 clinical trial. By minimizing the need for excipients, the SAMiRNA platform is anticipated to facilitate the development of safer siRNA drugs in the future. Therapeutic potential of SRN001 will be explored in subsequent clinical trials.
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