Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

Inclusion Criteria:

1. Participant has proven or probable IPA according to the modified 2019 EuropeanOrganization for Research and Treatment of Cancer/ Mycoses Study Group Education andResearch Consortium (EORTC/MSGERC) consensus definitions or according to the 2010International Society for Heart and Lung Transplantation (ISHLT) consensusstatements for the definitions of infections in cardiothoracic transplantrecipients.

2. Participant's IPA has failed to respond to adequate antifungal therapy.

Exclusion Criteria:

1. Participant with a known or suspected concomitant medical condition or post-surgerycomplication that, in the opinion of the Investigator, may jeopardize adherence tothe protocol requirements or impede the accurate measurement of efficacy or may bean unacceptable additional risk to the Participant should he/she participate in thestudy.

2. Participant who has previously received PC945.

3. Participant with a known history of allergy, hypersensitivity, or any previousserious reaction to any component of the PC945 or placebo formulations.

4. Participant who has recently received, is receiving or due to receive at any timeduring the study, an investigational medicinal agent that does not have anyregulatory approved indications. Subjects who are participating in any other trialse.g., Observational, diagnostic or using medications with an approved indication maybe allowed to participate after consultation with the sponsor on an individual basis