Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, IONIS AGT-Lrx
Brief summary
The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS AGT-LRx in up to 82 Healthy Volunteers
Interventions
DRUGIonis AGT-LRx
Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously
DRUGPlacebo
Saline .9%
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events that are related to treatment with IONIS AGT-LRx | Up to 127 days | The safety and tolerability of single and multiple doses of IONIS AGT-LRx will be assessed by determining the incidence, severity, and dose relationship of adverse events that are related to treatment with IONIS AGT-LRx |
| Any observed changes in Blood Pressure measurements, ECGs, or laboratory tests from baseline | Up to 127 days | The safety and tolerability of single and multiple doses of IONIS AGT-LRx will be assessed by reviewing any observed changes in Blood Pressure measurements, physical exam, and laboratory tests from baseline by dose. Results in subjects dosed with IONIS AGT-LRx will be compared with those from subjects dosed with placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics after single and multiple doses of IONIS AGT-LRx | Up to 127 days | The plasma pharmacokinetics (concentration-time results) of IONIS AGT-LRx will be assessed following single and multiple dose SC administration |
| Pharmacodynamics of IONIS AGT-LRx (Changes in plasma AGT Levels) | Up to 127 days | Effects of IONIS AGT-LRx on changes in AGT plasma protein compared to baseline. |
Countries
Canada
Outcome results
None listed