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drugset / Trial / NCT05521022

Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis

NCT05521022 ↗

Phase 1 Unknown 100 enrolled Attralus, Inc. Novotech (Australia) Pty Limited · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2022-09-01
Primary completion
2025-03-01
Completion
2025-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject AT02 Monoclonal antibody 30 mg Intravenous
Subject AT02 Monoclonal antibody 300 mg Intravenous
Subject AT02 Monoclonal antibody 1000 mg Intravenous
Subject AT02 Monoclonal antibody 4000 mg Intravenous

Indications

amyloidosis