Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VLX-1005 · 2 trials · 2 indications
Measure the effects of argatroban on the maximum plasma concentration (Cmax) of VLX-1005
Measure the effects of VLX-1005 on the maximum plasma concentration (Cmax) of argatroban
Measure the effects of argatroban on the time to maximum plasma concentration (Tmax) of VLX-1005
Measure the effects of VLX-1005 on the time to maximum plasma concentration (Tmax) of argatroban
Measure the effects of argatroban on the Area Under the Curve \[AUC(inf)\] of VLX-1005
Measure the effects of VLX-1005 on the Area Under the Curve \[AUC(inf)\] of argatroban
The change in impedance from baseline by whole blood aggregometry will be measured to assess the effects of VLX-1005 on platelet aggregation
The change in impedance from baseline by whole blood aggregometry will be measured to assess the effects of argatroban on platelet aggregation
Change in PFA-100 (a platelet pharmacodynamic measure) from baseline, to assess the effects of VLX-1005 on platelet aggregation
Change in PFA-100 (a platelet pharmacodynamic measure) from baseline, to assess the effects of argatroban on platelet aggregation
| Arm | Type | Description |
|---|---|---|
| VLX-1005 | EXPERIMENTAL | Intravenous administration of VLX-1005 with measurements of PK and PD |
| Argatroban | ACTIVE_COMPARATOR | Intravenous administration of argatroban with measurements of PK and PD |
| VLX-1005 and Argatroban | OTHER | Intravenous co-administration of VLX-1005 and argatroban with measurements of PK and PD |
| Single Ascending Dose Cohorts 1-6 | EXPERIMENTAL | Drug: VLX-1005 |
| Single Ascending Dose Cohorts 1-6, Placebo | PLACEBO_COMPARATOR | Drug: Placebo |
| Multiple Ascending Dose Cohorts 7-9 | EXPERIMENTAL | Drug: VLX-1005 |
| Multiple Ascending Dose Cohorts 7-9, Placebo | PLACEBO_COMPARATOR | Drug: Placebo |
| Name | Type | Description |
|---|---|---|
| VLX-1005 | DRUG | Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD |
| Argatroban | DRUG | Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD |
| Placebo | DRUG | Placebo infusion |
Inclusion Criteria: 1. Healthy, adult, male or female (non-lactating and not of childbearing potential) subjects age 19 to 55 inclusive. 2. Females must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing: 1. hysteroscopic sterilization 2....
VLX-1005 is an investigational small molecule being developed for heparin-induced thrombocytopenia, a condition related to blood clotting. It is also being studied for safety and tolerability in healthy volunteers. The drug is in Phase 1 clinical development and has not been approved by the FDA.
VLX-1005 is a small molecule being developed by Cadrenal Therapeutics for heparin-induced thrombocytopenia. The specific molecular target of VLX-1005 has not been disclosed in available information. The drug is currently in Phase 1 clinical trials to evaluate its safety and tolerability.
Cadrenal Therapeutics, Inc. (NASDAQ: CVKD) is developing VLX-1005. The company is conducting Phase 1 clinical trials for this investigational small molecule, which is being studied for heparin-induced thrombocytopenia and safety in healthy volunteers.
VLX-1005 is in Phase 1 clinical development. It has completed two Phase 1 trials, including one studying its co-administration with argatroban in healthy subjects. The drug is investigational and has not received FDA approval. It has been granted orphan drug and fast track designations.
VLX-1005 has completed two Phase 1 trials. NCT04783545 studied VLX-1005 in 96 healthy subjects in the United States. NCT05325346 studied co-administration of VLX-1005 and argatroban in 12 healthy subjects for heparin-induced thrombocytopenia. Both trials are completed.
No, VLX-1005 is not the same as argatroban. VLX-1005 is an investigational small molecule being developed by Cadrenal Therapeutics. Argatroban is a separate anticoagulant medication. A Phase 1 trial (NCT05325346) studied the co-administration of both drugs in healthy subjects.