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Safety, pharmacokinetics, and pharmacodynamics of the oral TLR8 agonist selgantolimod in chronic hepatitis B
Gane EJ, Kim HJ, Visvanathan K, et al
Hepatology|March 12, 2021
Given that activation of toll‐like receptor 8 (TLR8) may induce antiviral immunity and drive functional cure in patients with chronic hepatitis B (CHB) infection, researchers conducted this Phase 1b, randomized, blinded, placebo-controlled, multicenter study to characterize the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of selgantolimod, a novel TLR8 agonist, following multiple-dose administration to virally suppressed and viremic patients with CHB. Study participants were randomized 4:1 to obtain either selgantolimod or placebo once‐weekly. Virally suppressed patients were given either 1.5 mg (for two weeks) or 3 mg (for two weeks or four weeks). In total, 38 patients (28 virally suppressed, 10 viremic) were recruited from 6 sites in Australia, New Zealand, and South Korea. Headache, nausea and dizziness were the most common adverse events. In virally suppressed and viremic CHB patients, selgantolimod was found to be safe and well-tolerated, and it elicited cytokine responses that were consistent with target engagement. To determine efficacy, more research with longer durations of selgantolimod treatment is required.
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发表于 2021-3-13 14:50