Clinical trial · Interventional
Single Dose Study With 4SC-203 in Healthy Volunteers
First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers
NCT01054937CI-TRIAL-00004283completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4SC-203 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 4SC-203
- interventionNames
- Drug: 4SC-203
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Investigation of safety and tolerability of escalating single doses of 4SC-203.
- timeFrame
- 14 days
Secondary outcomes (2)
- measure
- To investigate the pharmacokinetics of single doses of 4SC-203.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.