Australian-New Zealand Clinical Trial: Evaluation of the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of AP03 (pirfenidone/nintedanib inhalation solution) in healthy volunteers.

Australia, Nov. 10 -- The Australian New Zealand Clinical Trials Registry (ANZCTR) received information related to the study titled ‘Evaluation of the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of AP03 (pirfenidone/nintedanib inhalation solution) in healthy volunteers.’. The following are the other relevant details related to the trial:

Trial ID: 392710

Submit Date: 9/26/26 1:42

Study Type: Interventional

Intervention: SAD: Single Ascending Dose will be conducted in up to 3 dose cohorts of 8 healthy volunteers each. The study will evaluate multiple dose levels of the combination therapy (pirfenidone/nintedanib), beginning at a low dose (50 mg pirfenidone/2 mg nintedanib) and escalating as appropria...