Phase I Trials
Safety phase I, first in-human clinical trial:
First time administration of O304 in human. A single centre study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics after oral administration of ascending single and multiple doses of 0304. A double-blind, placebo-controlled, within-cohort randomised study in healthy volunteers and uncomplicated type 2 diabetic patients. Including an additional exploratory evaluation of drug-drug-interaction with simvastatin in a cohort with O304 once daily, not placebo-controlled, in healthy volunteers.
Capsule formulation PK-Study
An open-labelled, randomised, single-center, cross-over study investigating the relative bioavailability of a new capsule formulation of O304 in comparison to the previously used oral suspension of O304 in healthy male volunteers.
Bridging PK study O304 Na Salt
An open randomised, parallel-group study evaluating the exposure and safety of O304 Na salt after single and multiple dosing and in combination with Dapagliflozin (Forxiga) at steady state in healthy volunteers.
Phase IIa Trials
Proof of concept phase IIa clinical trial in type 2 diabetes – Oral solution
Effect on fasting plasma glucose of once daily oral administration during 28 days of O304 suspension in subjects with type-2 diabetes. A randomised parallel-group, double-blinded, placebo controlled Phase IIa study (Tellus)
Planned Clinical Trials
Phase I PK study O304 Na Salt Tablet: An open, randomised, parallel-group study evaluating the exposure and safety of two different doses of O304 Na-salt tablet at steady state in healthy volunteers.
HFpEF: Phase II study of O304 NA-salt in heart failure with preserved ejection fraction. No drug is approved for PR improves excessive capacity in HFpEF. Improvements in exercise capacity and heart failure symptoms key to HF patients.
DKD: Phase II study OF O304 NA-Salt +/- dapagliflozin in diabetic kidney disease to monitor reduction in proteinuria. AMPK a novel key target in diabetic kidney disease. O304 shows beneficial renal effects in humans.
O304 shows good safety & is well tolerated in man – Clean toxicology in 6 months rat and 9 months dog studies.