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Single Dose Study With 4SC-203 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
4SC AG
ClinicalTrials.gov Identifier:
NCT01054937
First received: January 21, 2010
Last updated: January 12, 2011
Last verified: January 2011

January 21, 2010
January 12, 2011
January 2010
November 2010   (final data collection date for primary outcome measure)
Investigation of safety and tolerability of escalating single doses of 4SC-203. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01054937 on ClinicalTrials.gov Archive Site
  • To investigate the pharmacokinetics of single doses of 4SC-203. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • To assess the pharmacodynamic effect by means of appropriate biomarkers. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: 4SC-203
    i.v. administration
  • Drug: Placebo
    i.v. administration
  • Experimental: 4SC-203
    Intervention: Drug: 4SC-203
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01054937
4SC-203-2-2009
Not Provided
Not Provided
4SC AG
Not Provided
Principal Investigator: Frank Wagner, PD Dr. med. Charité Research Organisation GmbH, Berlin, Germany
4SC AG
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP