Trial reportDrug design, development and therapy2026
Phase I, Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Safety, Tolerability, and Pharmacokinetics of BS1801 in Healthy Chinese Adult Subjects.
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. 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.
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Authors and funding
11 authors.
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Abstract
Background: Fibrosis is an excessive self-repair response affecting organs like the liver and lungs. Current treatments targeting local fibroblasts have significant adverse events (AEs). BS1801 is an organoselenium compound targeting thioredoxin reductase with anti-fibrotic activities. This Phase I study evaluated its safety, tolerability, and pharmacokinetics (PK) in healthy Chinese adults. Methods: This single-center, randomized, double-blind, placebo-controlled study enrolled 57 participants into single-dose (n=27) and multiple-dose (n=30) trials (placebo-to-drug ratios 1:3 and 1:4). Single doses of 450, 900, 1200, and 1800 mg were tested; multiple doses of 300, 450, and 600 mg twice daily (12±0.5h apart) were investigated. Results: All participants completed the study. Thirty-six treatment-emergent AEs were reported, including 14 in 9 participants (20%, 95% CI: 8.3-31.7%) in single-dose, and 22 in 11 participants (24.4%, 95% CI: 11.9-37.0%) in multiple-dose trials. All AEs were Grade I and resolved naturally; one constipation case required medication. Using BS1801-M2 as a surrogate biomarker, PK parameters increased proportionally with single doses (450-1800 mg): T Conclusion: BS1801 is safe and well-tolerated at tested doses. Based on safety and PK profiles, the recommended dosage is 300-450 mg twice daily. Further clinical studies are needed for evaluating the safety and efficacy of BS1801 in the target population.
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