Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple… (NCT04803396) | Clinical Trial Compass
TerminatedPhase 1
Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A
Stopped: The Sponsor decided to not proceed from SAD to MAD to explore the possibility of further studying PD.
France32 participantsStarted 2018-11-15
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Healthy male subject, aged between 18 and 55 years inclusive;
✓. Healthy female subject infertile or in post menopause for at least two years, aged between 18 and 60 years inclusive;
✓. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weight ≤ 90kg;
✓. Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
✓. Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position:
✓. Smoker \< 5cigarettes per day who stop totally during the study;
✓. Normal ECG recording on a 12-lead ECG at the screening visit:
✓. Normal oral temperature;
Exclusion criteria
✕. Subject has had a clinically significant illness in the six weeks before screening in the opinion of the Investigator.
. Subject has had a serious adverse reaction or significant hypersensitivity to any drug, has a known clinically significant allergy to anti-inflammatory drugs or chemically related compounds or has a clinically significant allergy to drugs, foods or other materials (in the opinion of the Investigator). However, subjects with mild hayfever may be included in the study.
✕. Subject has used prescription medication in the 14 days prior to dosing or over-the-counter preparations for 7 days prior to dosing (including vitamin supplements and herbal remedies), with the exception of paracetamol which was allowed during the study (maximum 500 mg per administration, total daily dose maximum 2 grams).
✕. Subject has a significant history of drug/solvent abuse or a positive drugs of abuse (DOA) test at any time during the study.
✕. Subject has a history of alcohol abuse in the last 5 years or currently drinks in excess of 21 and 14 units per week for males and female, respectively, or has a positive alcohol breath test (ABT) at any time during the study.
✕. Subject is not willing to refrain from caffeine/xanthine containing products in the 48 hours prior to admission to the clinical unit on Day -1 and for the duration of the residential period.
✕. Subject who has a positive human immunodeficiency virus (HIV) screen, Hepatitis B screen or Hepatitis C screen.
✕. Subject has donated blood or blood products (e.g., plasma or platelets) within the three months prior to screening.