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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac repolarization, specifically, Fridericia's QT-Interval (QTcF)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANX-188 Therapeutic dose level | Experimental | IV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours |
|
| ANX-188 Supratherapeutic dose | Experimental | IV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours |
|
| Saline | Placebo Comparator | IV administration. Six hour infusion. |
|
| Moxifloxacin | Active Comparator | Oral tablet. 400 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANX-188 Therapeutic Dose | Drug |
|
| |
| ANX-188 Supratherapeutic dose |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF) | Day 1 Pre-dose to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Bazett's corrected QT-interval (QTcB) | Pre-dose to 24 hours post-dose | |
| Heart rate measurements on treatment compared to time-matched baseline and placebo | Pre-dose to 24 hours post-dose | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edwin L Parsley, D.O. | Mast Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | 20201 | United States |
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Saline | Drug |
|
|
| Moxifloxacin | Drug |
|
|
| RR-interval on treatment compared to time-matched baseline and placebo |
| Pre-dose to 24 hours post-dose |
| QRS measurements on treatment compared to time-matched baseline and placebo | Pre-dose to 24 hours post-dose |
| PR interval measurements on treatment compared to time-matched baseline and placebo | Pre-dose to 24 hours post-dose |
| Overall characterization of normal and abnormal ECGs and the number and percentage of subjects with normal and abnormal ECGs | Pre-dose to 24 hours post-dose |
| Number and percentage of subjects that develop abnormalities of repolarization on treatment | Pre-dose to 24 hours post-dose |
| Number and percentage of subjects the develop abnormal U waves | Pre-dose to 24 hours post-dose |
| Relationship between changes from the baseline and placebo in QTcF (DDQTcF) | Pre-dose to 24 hours post-dose |
| Analysis for arrhythmias | Pre-dose to 24 hours post-dsoe |
| Correlation of ECG findings with clinical adverse events | Pre-dose to 24 hours post-dose |
| D017670 |
| Sodium Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |