Safety, tolerability, pharmacokinetics and pharmacodynamics of the spleen tyrosine kinase inhibitor BI 894416 in healthy volunteers and patients with asthma
Phase I and Ib studies show BI 894416 is safe and well tolerated, indicating potential for reducing inflammation in asthma patients.
Key Points
The main aim was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 894416 in healthy volunteers and patients with asthma.
Conducted a single-blinded, placebo-controlled Phase I study in healthy volunteers with doses of 3-70 mg
Performed a Phase Ib study in asthma patients with single doses (75-170 mg) and multiple doses (10-60 mg) over 9 days
Assessed drug-related adverse events (AEs) and evaluated pharmacokinetics and cellular effects in asthma patients.
56 healthy volunteers and 68 asthma patients completed the treatment
Most common drug-related AEs included headache, diarrhea, and nausea, all of mild to moderate intensity
No serious AEs were reported, and BI 894416 was absorbed quickly with peak concentrations occurring at 0.5-1.0 hours
Dose-dependent effects on activation-related genes in basophils and nasal epithelial cells suggest potential efficacy.
Cite This Study
Carstensen-Aurèche et al. (2026) studied this question.