Study Developed to Evaluate the Effect of ANG-3777 on QT/QTc Interval

Study Overview
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Brief Summary
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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.

Official Title
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A Single Part, Four-Way Crossover, Randomized, Partially-Blinded Study to Evaluate the Effect of Intravenous ANG-3777 on Baseline-Adjusted QT/QTc Interval in the Fasted State in Healthy Male and Female Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: ANG-3777 (Therapeutic Dose)
* Drug: ANG-3777 (Supra-therapeutic Dose)
* Drug: Placebo
* Drug: Moxifloxacin Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or non-pregnant, non-lactating healthy females Aged 18 to 55 years inclusive at the time of signing informed consent Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening Weight ≥50 kg and ≤100 kg at screening and admission Must be willing and able to comply with all study requirements Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures Must agree to use an adequate method of contraception Exclusion Criteria: Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days. Subjects who are study site or sponsor employees, or are immediate family members of a study site or sponsor employee Evidence of current SARS-CoV-2 infection History of any drug or alcohol abuse in the past 2 years Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine) A confirmed positive alcohol urine test at screening or admission Current smokers and those who have smoked within the last 12 months or current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months A confirmed positive urine cotinine test at screening or admission. Positive drugs of abuse test result

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANG-3777 (Therapeutic Dose)<br>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. | Drug: ANG-3777 (Therapeutic Dose)<br>* Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted<br>* Other names: Hepatocyte growth factor mimetic;|
| Placebo Comparator: Normal Saline<br>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. | Drug: Placebo<br>* Arms assigned to this intervention will receive normal saline, IV, Fasted<br>* Other names: Normal Saline;|
| Active Comparator: Moxifloxacin Hydrochloride<br>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. | Drug: Moxifloxacin Hydrochloride<br>* Arms assigned to this intervention will receive 400 mg, Oral, Fasted<br>|
| Experimental: ANG-3777 (Supra-therapeutic Dose)<br>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. | Drug: ANG-3777 (Supra-therapeutic Dose)<br>* Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted<br>* Other names: Hepatocyte growth factor mimetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |