药代动力学
耐受性
安慰剂
药理学
医学
化学
不利影响
病理
替代医学
作者
Amita Datta‐Mannan,Arie Regev,David E. Coutant,Andrew J. Dropsey,Joanne Foster,Spencer B. Jones,Josh Poorbaugh,Carsten Schmitz,Evan Wang,Michael E. Woodman
摘要
For some patients with psoriasis, orally administered small molecule inhibitors of interleukin (IL)-17A may represent a convenient alternative to IL-17A-targeting monoclonal antibodies. This first-in-human study assessed the safety, tolerability, pharmacokinetics (PKs), and peripherally circulating IL-17A target engagement profile of single or multiple oral doses of the small molecule IL-17A inhibitor LY3509754 (NCT04586920). Healthy participants were randomly assigned to receive LY3509754 or placebo in sequential escalating single ascending dose (SAD; dose range 10-2,000 mg) or multiple ascending dose (MAD; dose range 100-1,000 mg daily for 14 days) cohorts. The study enrolled 91 participants (SAD, N = 51 and MAD, N = 40) aged 21-65 years (71% men). LY3509754 had a time to maximum concentration (T
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