Study Developed to Evaluate the Effect of ANG-3777 on QT/QTc Interval
Phase 1
- Conditions
- Healthy Volunteer
- Interventions
- Drug: ANG-3777 (Therapeutic Dose)Drug: PlaceboDrug: ANG-3777 (Supra-therapeutic Dose)
- Registration Number
- NCT04898907
- Lead Sponsor
- Angion Biomedica Corp
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ANG-3777 (Therapeutic Dose) ANG-3777 (Therapeutic Dose) 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 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 Moxifloxacin Hydrochloride 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) ANG-3777 (Supra-therapeutic Dose) 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Sciences
🇺🇸Miami, Florida, United States