Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
Primary objective: •To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adult male and female volunteers. Secondary Objectives: * To determine the pharmacokinetics parameters of DF2755A * To establish a dose concentration-response relationship over a wide range of doses in order to select a narrower range of dose and dosing regimen to be subsequently studied in patients after single administration * To evaluate the effect of ascending single doses on the pharmacodynamics parameters * To compare metabolites pathway in Human with the one observed in animals Please note that the study has been closed after Part A (single ascending doses), so all the objectives were revised accordingly.
Epistemonikos ID: 12723e0f931f58f63a96f1079961585f821355a5
First added on: May 08, 2024