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

Angion

Status and phase: Unknown; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ANG-3777 (Therapeutic Dose); Drug: Moxifloxacin Hydrochloride; Drug: Placebo; Drug: ANG-3777 (Supra-therapeutic Dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04898907

ANG3777-HV5-104

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups, including a placebo group

ANG-3777 (Therapeutic Dose)

Experimental group

Description:

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.

Treatment:

Drug: ANG-3777 (Therapeutic Dose)

Normal Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Moxifloxacin Hydrochloride

Active Comparator group

Description:

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.

Treatment:

Drug: Moxifloxacin Hydrochloride

ANG-3777 (Supra-therapeutic Dose)

Experimental group

Description:

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.

Treatment:

Drug: ANG-3777 (Supra-therapeutic Dose)