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

NCT ID: NCT04898907

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-09-30

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

ANG-3777 (Therapeutic Dose)

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Moxifloxacin Hydrochloride

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

ANG-3777 (Supra-therapeutic Dose)

Intervention Type: DRUG

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

Interventions

ANG-3777 (Therapeutic Dose)

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

Intervention Type: DRUG

ANG-3777 (Supra-therapeutic Dose)

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Moxifloxacin Hydrochloride

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

Intervention Type: DRUG

Other Intervention Names

Hepatocyte growth factor mimetic; Hepatocyte growth factor mimetic; Normal Saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quotient Sciences

INDUSTRY

Sponsor Role: collaborator

Angion Biomedica Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Levy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Quotient Sciences - Miami, Inc.

Locations

Quotient Sciences

Miami, Florida, United States

Countries

United States

Central Contacts

Chantal Swiszcz

Role: CONTACT

cswiszcz@angion.com

857-378-4175

Martin Robledo

Role: CONTACT

mrobledo@angion.com

857-378-4173

Facility Contacts

Jeffrey Levy, MD, PhD

Role: primary

jeffery.levy@quotientsciences.com

305-644-9903 ext. 166

Other Identifiers

ANG3777-HV5-104

Identifier Type: -

Identifier Source: org_study_id