drugset
drugset / Trial / NCT06558097

Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants

NCT06558097 ↗

Phase 1 Completed 77 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindOther

Summary

This study was a randomized, participant and investigator-blinded, placebo-controlled, single-ascending dose study, consisting of 9 sequential dose cohorts (1 mg, 3 mg, 10 mg, 30 mg, 60 mg, 120 mg, 240 mg, 450 mg and 600 mg) and a Japanese ethnic sensitivity cohort (240 mg dose)

Timeline

Start
2020-07-29
Primary completion
2023-03-02
Completion
2023-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject XXB750 Monoclonal antibody 1 mg Subcutaneous
Subject XXB750 Monoclonal antibody 3 mg Subcutaneous
Subject XXB750 Monoclonal antibody 10 mg Subcutaneous
Subject XXB750 Monoclonal antibody 30 mg Subcutaneous
Subject XXB750 Monoclonal antibody 60 mg Subcutaneous
Subject XXB750 Monoclonal antibody 120 mg Subcutaneous
Subject XXB750 Monoclonal antibody 240 mg Subcutaneous
Subject XXB750 Monoclonal antibody 450 mg Subcutaneous
Subject XXB750 Monoclonal antibody 600 mg Subcutaneous

Indications

No indication recorded.