Healthy Volunteer
Conditions
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.
Interventions
DRUGANG-3777 (Therapeutic Dose)
Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted
DRUGANG-3777 (Supra-therapeutic Dose)
Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted
DRUGPlacebo
Arms assigned to this intervention will receive normal saline, IV, Fasted
Arms assigned to this intervention will receive 400 mg, Oral, Fasted
Sponsors
Quotient Sciences
Angion Biomedica Corp
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males or non-pregnant, non-lactating healthy females 2. Aged 18 to 55 years inclusive at the time of signing informed consent 3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening 4. Weight ≥50 kg and ≤100 kg at screening and admission 5. Must be willing and able to comply with all study requirements 6. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures 7. Must agree to use an adequate method of contraception
Exclusion criteria
1. 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. 2. Subjects who are study site or sponsor employees, or are immediate family members of a study site or sponsor employee 3. Evidence of current SARS-CoV-2 infection 4. History of any drug or alcohol abuse in the past 2 years 5. 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) 6. A confirmed positive alcohol urine test at screening or admission 7. 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 8. A confirmed positive urine cotinine test at screening or admission. 9. Positive drugs of abuse test result
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactChantal Swiszcz
Backup ContactMartin Robledo
Outcome results
None listed