Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis

Main Inclusion Criteria:

• Patients must have the below proven, probable or possible deep mycosis;

• invasive aspergillosis
• chronic pulmonary aspergillosis
• mucormycosis
• cryptococcosis
• Female patients must be non-lactating and at no risk for pregnancy.

Main Exclusion Criteria:

• Women who are pregnant or breastfeeding.
• Patients with hypersensitivity to any of the components of the azole class of antifungals or the investigational product.
• Patients at high risk for QT/QTc prolongation, or patients with risk factors for torsades de pointes, or taking concomitant medications known to prolong the QT/QTc interval.
• Patients with a history of short QT syndrome.
• Patients with liver dysfunction at enrollment.
• Patients with moderate to severe kidney dysfunction at enrollment.
• Patients who receive prohibited concomitant drugs.
• Patients with any other fungal infection other than Aspergillus species, order Mucorales, or Cryptococcus species.
• Patients who are not expected to survive study duration.
• Patients with an underlying disease, complication or general condition that would complicate safety and efficacy evaluations.
• Patients with a history of taking voriconazole for deep mycosis and showing no response to this treatment.
• Patients taking systemic antifungals who are unable to stop taking these drugs during the study, or who are showing signs of improvement in their symptoms of deep mycosis as a result of these drugs.