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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04898907
• Other study ID #: ANG3777-HV5-104
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2021
• Est. completion date: September 2021

Study information

• Verified date: May 2021
• Source: Angion Biomedica Corp
• Contact: Chantal Swiszcz
• Phone: 857-378-4175
• Email: cswiszcz[@]angion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ANG-3777 (Therapeutic Dose)
Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted
• ANG-3777 (Supra-therapeutic Dose)
Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted
• Placebo
Arms assigned to this intervention will receive normal saline, IV, Fasted
• Moxifloxacin Hydrochloride
Arms assigned to this intervention will receive 400 mg, Oral, Fasted

Locations

Country	Name	City	State
United States	Quotient Sciences	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Angion Biomedica Corp	Quotient Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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