HAB48358: A phase 1b open-label, dose-escalating study evaluating the safety, tolerability, pharmacokinetics and early signs of biological activity of Danegaptide following oral administration in subjects with Diabetic Macular Edema (DME) (BREYE-C22-1005)

Research summary

This is a multicenter, sequential-group, open-label, uncontrolled, dose-escalating Phase 1b study assessing the safety, tolerability, pharmacokinetics (PK), metabolite profile, and early signs of biological activity following oral administration of danegaptide in participants diagnosed with DME. A total of 4 cohorts are planned to explore escalating doses (75 and 150 mg) and/or different dosing frequencies (once and twice daily) of danegaptide. • Cohort 1: 75 mg once daily (morning before breakfast) • Cohort 2: 75 mg twice daily (morning before breakfast and evening at bedtime) • Cohort 3: 150 mg once daily (morning before breakfast) • Cohort 4: 150 mg twice daily (morning before breakfast and evening at bedtime).

Principal Investigator

Dr Christine Kiire

Contact us

Email: ERGO@ouh.nhs.uk

IRAS number

1007664