Acute Myeloid Leukemia
Conditions
Keywords
4SC-203, Phase I, single dose, healthy volunteers
Brief summary
The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.
Interventions
DRUG4SC-203
i.v. administration
DRUGPlacebo
i.v. administration
Sponsors
4SC AG
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects aged 18 to 45 years (included), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening * Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and to understand and sign the written informed consent
Exclusion criteria
* Evidence of current or previous clinically significant disease, medical condition or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator would compromise the safety of the subject or the quality of the data * Current or recent history of significant renal, hepatic, haematological, immunological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of safety and tolerability of escalating single doses of 4SC-203. | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the pharmacokinetics of single doses of 4SC-203. | 14 days |
| To assess the pharmacodynamic effect by means of appropriate biomarkers. | 14 days |
Countries
Germany
Outcome results
None listed