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

May 27, 2021 updated by: Angion Biomedica Corp

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted
Other Names:
  • Hepatocyte growth factor mimetic
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
Arms assigned to this intervention will receive normal saline, IV, Fasted
Other Names:
  • Normal Saline
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
Arms assigned to this intervention will receive 400 mg, Oral, Fasted
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)
Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted
Other Names:
  • Hepatocyte growth factor mimetic

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Day 1, Day 5, Day 9 and Day 13
Day 1, Day 5, Day 9 and Day 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angion Biomedica Corp

Collaborators

Quotient Sciences

Investigators

  • Principal Investigator: Jeffrey Levy, MD, PhD, Quotient Sciences - Miami, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANG3777-HV5-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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