Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioInvent International AB | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMWH arm - active LMWH | Experimental |
| |
| LMWH arm - placebo | Placebo Comparator |
| |
| Warfarin arm - active warfarin | Experimental |
| |
| Warfarin arm - control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects | Drug | Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin |
| Measure | Description | Time Frame |
|---|---|---|
| Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c | To study end |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in safety parameters over time, PK parameters estimated by NCA, effect of LMWH in TB-402 treated subjects assessed by anti factor Xa (LMWH arm) | To study end |
Not provided
Inclusion Criteria include:
Exclusion Criteria include:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas J Jensen, MD, PhD | Cyncron CRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cyncron CRU | Copenhagen | Denmark |
Not provided
| ID | Term |
|---|---|
| C559990 | TB 402 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided