Safety, Tolerability, and Pharmacokinetics After a Single Dose of Orally Inhaled DNAzyme Solution for Nebulisation in Male Patients With Asthma

"Three consecutive ascending dose groups (A, B, and C) are planned, with a total of 24 patients with asthma. Each dose group will consist of 8 patients (n=6 receiving active drug and n=2 receiving placebo). Each patient will participate in one dose group only.~Dose escalation to the second and third dose level will occur after satisfactory review of safety and tolerability and after review of the pharmacokinetic data (exposure control, up to 4 hours after administration) of the preceding dose group by the Safety Board.~Dose levels:~Dose group A: 5 mg hgd40 in 2 mL solution (concentration: 2.5 mg/mL); Dose group B: 10 mg hgd40 in 2 mL solution (concentration: 5.0 mg/mL); Dose group C: 20 mg hgd40 in 2 mL solution (concentration: 10.0 mg/mL)."

"Three consecutive ascending dose groups (A, B, and C) are planned, with a total of 24 patients with asthma. Each dose group will consist of 8 patients (n=6 receiving active drug and n=2 receiving placebo). Each patient will participate in one dose group only.~Dose escalation to the second and third dose level will occur after satisfactory review of safety and tolerability and after review of the pharmacokinetic data (exposure control, up to 4 hours after administration) of the preceding dose group by the Safety Board."