The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS AGT-LRx in up to 82 Healthy Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously
Saline .9%
Syneos Health
Toronto, Ontario, Canada
Incidence and severity of adverse events that are related to treatment with IONIS AGT-LRx
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
Time frame: Up to 127 days
Any observed changes in Blood Pressure measurements, ECGs, or laboratory tests from baseline
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.
Time frame: Up to 127 days
Pharmacokinetics after single and multiple doses of IONIS AGT-LRx
The plasma pharmacokinetics (concentration-time results) of IONIS AGT-LRx will be assessed following single and multiple dose SC administration
Time frame: Up to 127 days
Pharmacodynamics of IONIS AGT-LRx (Changes in plasma AGT Levels)
Effects of IONIS AGT-LRx on changes in AGT plasma protein compared to baseline.
Time frame: Up to 127 days
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