Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03101878 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers | PHASE1 | COMPLETED | 62 | — | — | Apr 5, 2017 | Aug 1, 2018 | Aug 21, 2018 | 1 | Canada |
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
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.
| Arm | Type | Description |
|---|---|---|
| Ionis AGT-LRx | EXPERIMENTAL | Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously. |
| Placebo | PLACEBO_COMPARATOR | Saline .9% |
| Name | Type | Description |
|---|---|---|
| Ionis AGT-LRx | DRUG | Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously |
| Placebo | DRUG | Saline .9% |
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 po...