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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
Sponsor:
Information provided by:
4SC AG

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: 4SC-203 Drug: Placebo Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 4SC-203 Drug: 4SC-203
i.v. administration
Placebo Comparator: Placebo Drug: Placebo
i.v. administration


Outcome Measures
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Primary Outcome Measures :
  1. Investigation of safety and tolerability of escalating single doses of 4SC-203. [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. To investigate the pharmacokinetics of single doses of 4SC-203. [ Time Frame: 14 days ]
  2. To assess the pharmacodynamic effect by means of appropriate biomarkers. [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Germany
Charité Research Organisation
Berlin, Germany
Sponsors and Collaborators
4SC AG
Investigators
Principal Investigator: Frank Wagner, PD Dr. med. Charité Research Organisation GmbH, Berlin, Germany
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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