Single Dose Study With 4SC-203 in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01054937 |
Recruitment Status
:
Completed
First Posted
: January 22, 2010
Last Update Posted
: January 13, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myeloid Leukemia | Drug: 4SC-203 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 4SC-203 |
Drug: 4SC-203
i.v. administration
|
Placebo Comparator: Placebo |
Drug: Placebo
i.v. administration
|
- Investigation of safety and tolerability of escalating single doses of 4SC-203. [ Time Frame: 14 days ]
- To investigate the pharmacokinetics of single doses of 4SC-203. [ Time Frame: 14 days ]
- To assess the pharmacodynamic effect by means of appropriate biomarkers. [ Time Frame: 14 days ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054937
Germany | |
Charité Research Organisation | |
Berlin, Germany |
Principal Investigator: | Frank Wagner, PD Dr. med. | Charité Research Organisation GmbH, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT01054937 History of Changes |
Other Study ID Numbers: |
4SC-203-2-2009 |
First Posted: | January 22, 2010 Key Record Dates |
Last Update Posted: | January 13, 2011 |
Last Verified: | January 2011 |
Keywords provided by 4SC AG:
4SC-203 Phase I single dose healthy volunteers |
Additional relevant MeSH terms:
Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia Neoplasms by Histologic Type Neoplasms |