What's happened?
Amplia Therapeutics Limited (ASX: ATX, "Amplia") has received clearance from the Alfred Hospital Human Research Ethics Committee (HREC) to conduct a Phase 1 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945, in healthy volunteers.
What are the key highlights?
- With this clearance in hand, Amplia expects to initiate its Phase 1 trial in the coming weeks with the first subject likely to be dosed by early October.
- The double blind, placebo-controlled Phase 1 trial is designed to establish the safety profile of oral doses of AMP945 in up to 64 healthy adult volunteers.
- Amplia is on track to complete dosing of subjects for the single ascending dose (SAD) component of the Phase 1 trial by the end of the year and have data from the completed trial in the first half of 2021.
- Data from this trial will be used to support Phase 2 clinical trials of AMP945 for the treatment of patients with specific, hard-to-treat cancers or with certain fibrotic diseases.
For further information, please refer to the announcement linked below.
