Status:
UNKNOWN
Study Developed to Evaluate the Effect of ANG-3777 on QT/QTc Interval
Lead Sponsor:
Angion Biomedica Corp
Collaborating Sponsors:
Quotient Sciences
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04898907
Start Date
June 1 2021
End Date
September 1 2021
Last Update
June 1 2021
Active Locations (1)
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1
Quotient Sciences
Miami, Florida, United States, 33126