Single Dose Study With 4SC-203 in Healthy Volunteers - Full Text View

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:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

Genetic and Rare Diseases Information Center resources: Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Non Lymphoblastic Leukemia Leukemia, Myeloid

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

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 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, Myeloid Leukemia, Myeloid, Acute Leukemia Neoplasms Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 25, 2015