Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A
Status:
Completed
Trial end date:
2020-03-13
Target enrollment:
Participant gender:
Summary
Primary objective:
•To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy
adultmale 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 toselect a narrower range of dose and dosing regimen to be subsequently studied in
patients aftersingle 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