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| Sponsor: | Noxxon Pharma AG |
|---|---|
| Collaborator: |
German Federal Ministry of Education and Research |
| Information provided by (Responsible Party): | Noxxon Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00976378 |
Purpose
This is the first time NOX-A12 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous (IV) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses and dosage regimen of administration suitable for subsequent studies in the patient population.
| Condition | Intervention | Phase |
|---|---|---|
|
Autologous Stem Cell Transplantation |
Drug: NOX-A12 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | NOX-A12 to Mobilize Stem Cells in Healthy Volunteers - A Single-center, Single Dose, Open Label, Dose Escalation Study of Intravenous NOX-A12 in up to 48 Healthy Subjects |
| Enrollment: | 48 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 0.05 mg/kg NOX-A12 |
Drug: NOX-A12
single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg
|
| Experimental: 0.15 mg/kg NOX-A12 |
Drug: NOX-A12
single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg
|
| Experimental: 0.45 mg/kg NOX-A12 |
Drug: NOX-A12
single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg
|
| Experimental: 1.35 mg/kg NOX-A12 |
Drug: NOX-A12
single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg
|
| Experimental: 2.7 mg/kg NOX-A12 |
Drug: NOX-A12
single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg
|
| Experimental: 5.4 mg/kg NOX-A12 |
Drug: NOX-A12
single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg
|
| Experimental: 10.8 mg/kg NOX-A12 |
Drug: NOX-A12
single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg
|
| Experimental: 5.4 mg/kg NOX-A12 plus apheresis |
Drug: NOX-A12
single IV dose, at efficacious dose level
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Noxxon Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00976378 History of Changes |
| Other Study ID Numbers: | SNOXA12C001 |
| Study First Received: | September 9, 2009 |
| Last Updated: | November 8, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
stromal cell-derived factor-1 (SDF-1) L-oligonucleotide aptamer Spiegelmer |