Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers

Ionis Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: Ionis AGT-LRx

Study type

Interventional

Funder types

Industry

Identifiers

ISIS 757456-CS1

Details and patient eligibility

About

The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS AGT-LRx in up to 82 Healthy Volunteers

Enrollment

62 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Must have given written informed consent and be able to comply with all study requirements
Healthy males or females aged 18-60 inclusive and weighing ≥ 50 kg at the time of Informed Consent
Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
Males must be surgically sterile, abstinent or using an acceptable contraceptive method
BMI ≤ 35 kg/m
Agree to conduct at home blood pressure monitoring (in triplicate using study provided device) every morning and every evening throughout study participation for Single-Dose Cohort subjects and every morning for Multiple-Dose Cohort subjects

Exclusion criteria

Treatment with another Study Drug, biological agent, or device within one-month of Screening
Subject with borderline orthostatic hypotension defined as a fall in systolic blood pressure of ≥ 17 mmHg or diastolic blood pressure of ≥ 7 mmHg when they assume a standing position (within 3 minutes of standing up)
Use of nicotine-containing products or illicit drugs
Considered unsuitable for inclusion by the Principal Investigator