CClinicalTrials.gg
Status unknownNCT04898907Updated Jun 1, 2021

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

A Phase 1 interventional study of ANG-3777 (Therapeutic Dose) and ANG-3777 (Supra-therapeutic Dose) in Healthy Volunteer, sponsored by Angion Biomedica Corp. Status unknown at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-01.

Sponsored by Angion Biomedica Corp · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Angion Biomedica Corp is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: ANG-3777 (Therapeutic Dose)

  • Placebo comparator
    Normal Saline

    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

  • Active comparator
    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.

    Drug: Moxifloxacin Hydrochloride

  • Experimental
    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.

    Drug: ANG-3777 (Supra-therapeutic Dose)

Interventions

  • DrugANG-3777 (Therapeutic Dose)

    Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted

    Also known as: Hepatocyte growth factor mimetic

  • DrugANG-3777 (Supra-therapeutic Dose)

    Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted

    Also known as: Hepatocyte growth factor mimetic

  • DrugPlacebo

    Arms assigned to this intervention will receive normal saline, IV, Fasted

    Also known as: Normal Saline

  • DrugMoxifloxacin Hydrochloride

    Arms assigned to this intervention will receive 400 mg, Oral, Fasted

06

What researchers measure

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

    Time frame: Day 1, Day 5, Day 9 and Day 13

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04898907
Lead sponsor
Angion Biomedica Corp
Collaborators
Quotient Sciences
Responsible party
Sponsor
First posted
May 24, 2021
Start date
Jun 2021 (estimated)
Primary completion
Sep 2021 (estimated)
Completion
Sep 2021 (estimated)
Last update
Jun 1, 2021

Study contacts

Chantal Swiszcz
Contact
cswiszcz@angion.com
857-378-4175
Martin Robledo
Contact
mrobledo@angion.com
857-378-4173
Jeffrey Levy, MD, PhD
principal investigator · Quotient Sciences - Miami, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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