drugset / Trial / NCT00976378
NOX-A12 First-in-human (FIH) Study
Phase 1
Completed
48 enrolled
TME Pharma AG
German Federal Ministry of Education and Research · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2009-10
- Primary completion
- 2010-05
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaptesed pegol | Oligonucleotide (other) | 0.05 mg/kg | Intravenous |
| Subject | Olaptesed pegol | Oligonucleotide (other) | 0.15 mg/kg | Intravenous |
| Subject | Olaptesed pegol | Oligonucleotide (other) | 0.45 mg/kg | Intravenous |
| Subject | Olaptesed pegol | Oligonucleotide (other) | 1.35 mg/kg | Intravenous |
| Subject | Olaptesed pegol | Oligonucleotide (other) | 2.7 mg/kg | Intravenous |
| Subject | Olaptesed pegol | Oligonucleotide (other) | 5.4 mg/kg | Intravenous |
| Subject | Olaptesed pegol | Oligonucleotide (other) | 10.8 mg/kg | Intravenous |