Single Dose Study With 4SC-203 in Healthy Volunteers

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: 4SC-203; Drug: Placebo

• Registration Number: NCT01054937
• Lead Sponsor: 4SC AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-12
• Last Update Posted: 2011-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4SC-203	4SC-203	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Investigation of safety and tolerability of escalating single doses of 4SC-203.	14 days

Secondary Outcome Measures

Name	Time	Method
To investigate the pharmacokinetics of single doses of 4SC-203.	14 days
To assess the pharmacodynamic effect by means of appropriate biomarkers.	14 days

Trial Locations

Locations (1)

Charité Research Organisation; 🇩🇪 Berlin, Germany