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First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers


Phase 1
18 Years
45 Years
Not Enrolling
Male
Acute Myeloid Leukemia

Thank you

Trial Information

First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Investigation of safety and tolerability of escalating single doses of 4SC-203.

Outcome Time Frame:

14 days

Safety Issue:

Yes

Principal Investigator

Frank Wagner, PD Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Research Organisation GmbH, Berlin, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

4SC-203-2-2009

NCT ID:

NCT01054937

Start Date:

January 2010

Completion Date:

November 2010

Related Keywords:

  • Acute Myeloid Leukemia
  • 4SC-203
  • Phase I
  • single dose
  • healthy volunteers
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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