Study Developed to Evaluate the Effect of ANG-3777 on QT/QTc Interval
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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJune 1, 2021
May 1, 2021
3 months
May 19, 2021
May 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
ANG-3777 (Therapeutic Dose)
EXPERIMENTALAdministered 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 COMPARATORThe 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 COMPARATORThe 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)
EXPERIMENTALAdministered 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.
Interventions
Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted
Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted
Arms assigned to this intervention will receive normal saline, IV, Fasted
Arms assigned to this intervention will receive 400 mg, Oral, Fasted
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Angion Biomedica Corplead
- Quotient Sciencescollaborator
Study Sites (1)
Quotient Sciences
Miami, Florida, 33126, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Levy, MD, PhD
Quotient Sciences - Miami, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 24, 2021
Study Start
June 1, 2021
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
June 1, 2021
Record last verified: 2021-05