drugset / Trial / NCT05607199

A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics

NCT05607199

Phase 1 Terminated 27 enrolled Aurigene Discovery Technologies Limited
NaSequentialOpen-labelTreatment

Summary

A Phase I, Open Label, Dose-Escalation, First in Human (FIH) study evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR103 Calcium in patients with relapsed advanced malignancies (BHARAT-1).

Timeline

Start
2022-09-16
Primary completion
2024-11-27
Completion
2024-11-27

Drugs

EvaluationDrugModalityDoseRoute
Subject AUR103 Unknown 25 mg Oral
Subject AUR103 Unknown 50 mg Oral
Subject AUR103 Unknown 100 mg Oral
Subject AUR103 Unknown 200 mg Oral
Subject AUR103 Unknown 400 mg Oral