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Single Dose Study With 4SC-203 in Healthy Volunteers

This study has been completed.
Information provided by:
4SC AG Identifier:
First received: January 21, 2010
Last updated: January 12, 2011
Last verified: January 2011
The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: 4SC-203 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by 4SC AG:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4SC-203 Drug: 4SC-203
i.v. administration
Placebo Comparator: Placebo Drug: Placebo
i.v. administration


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01054937

Charité Research Organisation
Berlin, Germany
Sponsors and Collaborators
Principal Investigator: Frank Wagner, PD Dr. med. Charité Research Organisation GmbH, Berlin, Germany
  More Information Identifier: NCT01054937     History of Changes
Other Study ID Numbers: 4SC-203-2-2009
Study First Received: January 21, 2010
Last Updated: January 12, 2011

Keywords provided by 4SC AG:
Phase I
single dose
healthy volunteers

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms processed this record on September 20, 2017