What question did this study set out to answer?

The trial aimed to evaluate the safety, pharmacokinetics, and pharmacodynamics of LW402 in healthy participants to support its development for autoimmune diseases.

May 4, 2026SHILAP Revista de lepidopterología0 citationsOpen Access

Safety, tolerability, pharmacokinetics, and pharmacodynamics of LW402, a preferential Janus kinase 1 inhibitor in healthy volunteers: a randomized, double-blinded, placebo-controlled phase 1 trial

YGYuzhou GuiCenter for Drug Evaluation and Research FJFan JiangCenter for Drug Evaluation and Research LXLiang XinCenter for Drug Evaluation and Research

Key Points

The trial aimed to evaluate the safety, pharmacokinetics, and pharmacodynamics of LW402 in healthy participants to support its development for autoimmune diseases.
Randomized, double-blinded, placebo-controlled phase 1 trial with 90 healthy participants
Included single ascending doses (10–400 mg) and multiple ascending doses (50–150 mg, b.i.d for 6 days)
Safety and pharmacokinetics evaluated via blood samples and pharmacodynamics assessed through JAK1/JAK2 signaling
No serious adverse events reported; mild treatment-emergent adverse events included sinus bradycardia and gastrointestinal issues.
LW402 demonstrated rapid absorption with median t max of 0.42–1.0 hours and preferential inhibition of JAK1 signaling.

Abstract

Introduction This clinical trial aimed to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of LW402, a preferential JAK1 inhibitor, in healthy participants, so as to provide support for its further development in treating autoimmune diseases. Methods The study included two phases: a single ascending dose (10–400 mg) with 54 participants and a multiple ascending dose (50–150 mg, b.i.d for 6 days plus a single dose on day 7) with 36 participants. Safety, PK (from timed blood samples), and PD (JAK1/JAK2 signaling) were evaluated. Results No serious adverse events were reported; only mild treatment-emergent adverse events (TEAEs), such as sinus bradycardia and gastrointestinal issues, occurred. LW402 was rapidly absorbed (median t max : 0.42–1.0 hours), with slightly super-proportional exposure and minimal accumulation, and preferentially inhibited JAK1-mediated signaling. Discussion LW402’s favorable safety profile, predictable PK characteristics, and selective JAK1 inhibition collectively support its continued development for the treatment of autoimmune diseases. Clinical Trial Registration http://www.chinadrugtrials.org.cn , identifier CTR20201897.

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