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.
- Conditions
- MedDRA - LLT 10053943 (Hämatopoietische Stammzellmobilisierung/ Hematopoietic stem cell mobilization)MedDRA - LLT 10029547 (Non-Hodgkin's Lymphom / Non-Hodgkin's Lymphoma)MedDRA - LLT 10028233 (Multiples Myelom ohne erwähnte Remession / Multiple myeloma without mention of remission)C81Hodgkin lymphoma
- Registration Number
- DRKS00003104
- Lead Sponsor
- OXXON Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
•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.
•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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
- Secondary Outcome Measures
Name Time Method To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.<br>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.<br>