This is a multicenter, international, three-part, Phase 1 study designed to evaluate the safety, tolerability, and PK of rising single doses of AT-02 in healthy volunteers and in subjects with systemic amyloidosis and to assess the safety, tolerability, and PK of multiple doses of AT-02 in subjects with systemic amyloidosis.
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Incidence and severity of treatment-emergent adverse events (TEAEs) from Day 1 to end of study (EOS).
Timeframe: Up to 57+/-7 days
Incidence of dose-limiting toxicities (DLTs) in subjects with systemic amyloidosis.
Timeframe: Up to 85+/-7 Days
Incidence and frequency of abnormal and clinically significant abnormal clinical laboratory parameter values.
Timeframe: Up to 85+/-7 Days
Incidence of treatment-emergent anti-drug antibodies (ADA)
Timeframe: Up to 85+/-7 Days