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We report safety and tolerability of mosliciguat in healthy men.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Three randomized, single\u2010blinded, placebo\u2010controlled Phase 1 studies of mosliciguat DPI: a single\u2010dose escalation study (SDES) of mosliciguat 60\u20134000\u2009\u03bcg (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200978), a multiple\u2010dose escalation study (MDES) of seven once\u2010daily doses of 480\u20132000\u2009\u03bcg over 8\u00a0days (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200936) and a multiple\u2010dose study (MDS) of mosliciguat 1000\u2009\u03bcg for 14\u2009days (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200921).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Most adverse events (AEs) were mild, with no serious AEs or AEs leading to discontinuation. No clinically relevant lung function impairment or change in oxygen saturation was observed. In the MDES, body plethysmography indicated reduced airway resistance 6\u00a0h after dosing. Generally, no clinically relevant effect on blood pressure was seen; however, a few events of mild\u2010to\u2010moderate orthostatic hypotension occurred with higher doses in the SDES and MDS. In the SDES, there was a small, dose\u2010dependent heart rate increase with mosliciguat. Increased plasma cyclic guanosine monophosphate levels confirmed target engagement by mosliciguat. Overall, the PK profile of mosliciguat was appropriate for an inhaled therapy, with low systemic exposures and an effect on airway resistance consistent with targeted inhaled lung\u2010selective delivery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Mosliciguat DPI was well tolerated in healthy subjects, without AEs related to bronchospasm or airway irritation, with a pharmacodynamic response indicating sGC activation and a bronchodilating action.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70668","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T04:02:42Z","timestamp":1784865762000},"source":"Crossref","is-referenced-by-count":0,"title":["Safety and pharmacokinetics of mosliciguat, a new, inhaled soluble guanylate cyclase activator, in healthy adult 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