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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
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01054937     History of Changes
Other Study ID Numbers: 4SC-203-2-2009
Study First Received: January 21, 2010
Last Updated: January 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 4SC AG:
4SC-203
Phase I
single dose
healthy volunteers

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013