Single Dose Study With 4SC-203 in Healthy Volunteers

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054937
• Other study ID #: 4SC-203-2-2009
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2010
• Last updated: January 12, 2011
• Start date: January 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: 4SC AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• 4SC-203
i.v. administration
• Placebo
i.v. administration

Locations

Country	Name	City	State
Germany	Charité Research Organisation	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
4SC AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigation of safety and tolerability of escalating single doses of 4SC-203.		14 days	Yes
Secondary	To investigate the pharmacokinetics of single doses of 4SC-203.		14 days	No
Secondary	To assess the pharmacodynamic effect by means of appropriate biomarkers.		14 days	No