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Completed

NCT Number: NCT01054937

Single Dose Study With 4SC-203 in Healthy Volunteers

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

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Charité Research Organisation

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4SC-203

Drug

i.v. administration

Placebo

Drug

i.v. administration

Primary outcomes

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

    Time frame: 14 days

Secondary outcomes

  1. To investigate the pharmacokinetics of single doses of 4SC-203.

    Time frame: 14 days

  2. To assess the pharmacodynamic effect by means of appropriate biomarkers.

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

4SC AG

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2010
Registry last updated
Jan 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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