Trial document




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  DRKS00003104

Trial Description

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Title

A single center, open-label, repeated dose, Phase I study in healthy subjects to assess the safety, tolerability, pharmacokinetics and the effect on mobilization of hematopoietic stem cells of NOX-A12 alone and in combination with filgrastim.

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Trial Acronym

SNOXA12C101

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URL of the Trial

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Brief Summary in Lay Language

A single center, open-label, repeated dose, Phase I study in healthy subjects to assess the safety, tolerability, pharmacokinetics and the effect on mobilization of hematopoietic stem cells of NOX-A12 alone and in combination with filgrastim.

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Brief Summary in Scientific Language

This is the second clinical study of NOX-A12. This study intends to provide information on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination with filgrastim in healthy subjects. The results from this study will establish the basis for further development of NOX-A12 in lymphoma patients.

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Organizational Data

  •   DRKS00003104
  •   2011/06/08
  •   2010/09/02
  •   no
  •   Approved
  •   ZS EK 12 260/10, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   2010-020937-14 
  •   NCT01194934  (ClinicalTrial.gov)
  •   4036438 
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Health Condition or Problem studied

  •   LLT 10053943 (Hämatopoietische Stammzellmobilisierung/ Hematopoietic stem cell mobilization)
  •   LLT 10029547 (Non-Hodgkin's Lymphom / Non-Hodgkin's Lymphoma)
  •   LLT 10028233 (Multiples Myelom ohne erwähnte Remession / Multiple myeloma without mention of remission)
  •   C81 -  Hodgkin's disease
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Interventions/Observational Groups

  •   2.0 mg/kg NOX-A12 IV every day for 5 days
  •   4.0 mg/kg NOX-A12 IV every day for 5 days
  •   5 µg/kg filgrastim SC every day for 5 days
  •   Safe and efficacious dose of NOX-A12 IV in combination with filgrastim SC for 5 days. Based on PD data, a simultaneous or sequential dosing will be chosen.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Other
  •   I
  •   [---]*
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Primary Outcome

To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.

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Secondary Outcome

To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
To quantify the mobilization of HSCs in peripheral blood after repeated doses of NOX-A12 alone, of filgrastim alone and after the combination of NOX-A12 with filgrastim.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/08/30
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   55   Years
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Additional Inclusion Criteria

•Healthy male or female subjects aged 18-55 years of any ethnic origin.
•Body weight between 50 and 100 kg (extremes included).
•Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory parameters.
•Females of non-childbearing potential, defined as surgically sterile or post-menopausal.
•Males willing to use 2 means of contraceptive methods for at least 3 months after test substance administration.
•Normal lung function (FVC and FEV1 at least 80% of predicted values) at screening.
•Written consent to participate in the study.

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Exclusion Criteria

•Intake of vitamin A derivates or retinoids within 30 days prior to the start of drug administration.
•History of thrombosis.
•Chronic infection or acute infection or fever within the last 8 weeks prior to the start of drug administration.
•Subjects with a splenomegaly.
•Participation in another clinical study within three months prior to the start of drug administration.
•Blood donation (>100 ml) or a comparable blood loss within three months prior to the start of drug administration.
•Subjects who, in the investigator's opinion, may not be capable of following the study schedule for any reason.
•Subjects having already received G-CSF in the past.

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Addresses

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    • NOXXON Pharma AG
    • Max-Dohrn-Str. 8-10
    • 10589   Berlin
    • Germany
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    •   +49 30 726247-0
    •   +49 30 726247-201
    •   [---]*
    •   [---]*
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    • NOXXON Pharma AG
    • Mr.  Dr. med.  Frank  Fliegert 
    • Max-Dohrn-Str. 8-10
    • 10589  Berlin
    • Germany
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    • Charité Research Organisation GmbH
    • Mr.  Dr. rer. nat.  Andreas  Hüser 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/01/10
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.