Single Dose Study With 4SC-203 in Healthy Volunteers
First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 21, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJanuary 13, 2011
January 1, 2011
10 months
January 21, 2010
January 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigation of safety and tolerability of escalating single doses of 4SC-203.
14 days
Secondary Outcomes (2)
To investigate the pharmacokinetics of single doses of 4SC-203.
14 days
To assess the pharmacodynamic effect by means of appropriate biomarkers.
14 days
Study Arms (2)
4SC-203
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 4SC AGlead
Study Sites (1)
Charité Research Organisation
Berlin, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Wagner, PD Dr. med.
Charité Research Organisation GmbH, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 21, 2010
First Posted
January 22, 2010
Study Start
January 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
January 13, 2011
Record last verified: 2011-01