Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A
Summary
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.
Timeline
- Start
- 2018-11-15
- Primary completion
- 2019-06-29
- Completion
- 2019-06-29
Outcome
Outcome not reported
Stopped: “The Sponsor decided to not proceed from SAD to MAD to explore the possibility of further studying PD.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DF2755A | Unknown | 50 mg | Oral |
| Subject | DF2755A | Unknown | 150 mg | Oral |
| Subject | DF2755A | Unknown | 300 mg | Oral |
| Subject | DF2755A | Unknown | 600 mg | Oral |
Indications
No indication recorded.