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 |
|---|---|
| Quotient Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effect of ANG-3777 on placebo-corrected change from baseline, QT/corrected QT (QTc) interval, following single intravenous (IV) doses in healthy volunteer adults.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANG-3777 (Therapeutic Dose) | Experimental | Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration. |
|
| Normal Saline | Placebo Comparator | The placebo will be administered as a single dose on separate occasions intravenously as 30-minute infusions on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration. |
|
| Moxifloxacin Hydrochloride | Active Comparator | The comparator will be administered as a single dose oral Moxifloxacin Hydrochloride tablet (open-label), with a total of 240 mL of water. There will be a minimum washout of 3 days between each study drug administration. |
|
| ANG-3777 (Supra-therapeutic Dose) | Experimental | Administered IV as a single dose on two occasions for 30 minutes on the morning of Day 1 of each treatment period (total of 4), following an 8 hour overnight fast. There will be a minimum washout of 3 days between each study drug administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANG-3777 (Therapeutic Dose) | Drug | Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in corrected QT interval by Fridericia's formula for ANG-3777 at the therapeutic and supra-therapeutic dose levels compared to placebo | Day 1, Day 5, Day 9 and Day 13 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chantal Swiszcz | Contact | 857-378-4175 | cswiszcz@angion.com | |
| Martin Robledo | Contact | 857-378-4173 | mrobledo@angion.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Levy, MD, PhD | Quotient Sciences - Miami, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Miami | Florida | 33126 | United States |
Not provided
| ID | Term |
|---|---|
| C000711731 | terevalefim |
| D000077330 | Saline Solution |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Partially blinded study. Patients are blinded as to treatment assignment. Care Provider, Investigator, and Outcomes Assessor will be blinded to ANG-3777 IV or saline IV, but Moxifloxacin Hydrochloride pill will be provided open label.
| ANG-3777 (Supra-therapeutic Dose) | Drug | Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted |
|
|
| Placebo | Drug | Arms assigned to this intervention will receive normal saline, IV, Fasted |
|
|
| Moxifloxacin Hydrochloride | Drug | Arms assigned to this intervention will receive 400 mg, Oral, Fasted |
|
| D024841 |
| Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |