Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC 0128-0000-2011 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| 100 mcg/kg | EXPERIMENTAL | - |
| 200 mcg/kg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NNC 0128-0000-2011 | DRUG | Administered as one single i.v. (intravenous) injection, 100 mcg/kg |
| NNC 0128-0000-2021 | DRUG | Administered as one single i.v. (intravenous) injection, 100 mcg/kg |
Inclusion Criteria: * Body weight between 50.0 and 100.0 kg, both inclusive * Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive Exclusion Criteria: * Known or suspected hypersensitivity to trial product or related products, such as activated recombinant factor VII * Any clinical s...
NNC 0128-0000-2011 is an investigational small molecule being developed for congenital bleeding disorders, specifically haemophilia A and haemophilia B. It is in Phase 1 clinical development and has not been approved by regulatory authorities.
NNC 0128-0000-2011 is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO.
NNC 0128-0000-2011 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. Two Phase 1 trials have been completed, with a total of 27 participants enrolled.
NNC 0128-0000-2011 has been studied in two completed Phase 1 trials. NCT01272206 evaluated safety and pharmacokinetics in healthy male subjects in the United Kingdom. NCT01288391 evaluated two different single doses in male patients with haemophilia A or B in Germany, Japan, and Spain.
NNC 0128-0000-2011 is distinct from NNC 0128-0000-2021. In a clinical trial, NNC 0128-0000-2011 was compared directly to NNC 0128-0000-2021 to investigate their safety and pharmacokinetic profiles in healthy male subjects.