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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020937-14 | EudraCT Number |
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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. A single center, open-label, repeated dose study design is selected to best address the study objectives.The results from this study will establish the basis for further development of NOX-A12 in lymphoma patients undergoing autologous hematopoietic stem cell transplantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A: 2.0 mg/kg NOX-A12 IV every day for 5 days |
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| Group B | Experimental | Group B: 4.0 mg/kg NOX-A12 IV every day for 5 days |
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| Group C | Active Comparator | The treatment groups will enter the study sequentially. The decision on starting groups C and D will be made after groups A and B have been completed and data are available. Group C: 5 µg/kg filgrastim SC every day for 5 days |
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| Group D | Experimental | The treatment groups will enter the study sequentially. The decision on starting groups C and D will be made after groups A and B have been completed and data are available. Group D: Safe and efficacious dose of NOX-A12 IV in combination with filgrastim SC for 5 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOX-A12 | Drug | 4 mg/kg daily IV for 5 days |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects. | 1 month | |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Fliegert, MD | TME Pharma AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | Germany |
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| ID | Term |
|---|---|
| C587878 | NOX-A12 |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| NOX-A12 | Drug | 2 mg/kg daily IV for 5 days |
|
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| Filgrastim | Drug | 5 µg/kg SC daily for 5 days |
|
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| NOX-A12 in combination with Filgrastim | Drug | Safe and efficacious dose regimen according to results of groups A and B |
|
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| 1 month |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |