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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02900027 | Safety, Tolerability, PK, and Pharmacodynamics(PD) of IONIS APOCIII-LRx in Healthy Volunteers With Elevated Triglycerides | PHASE1 | COMPLETED | 56 | — | — | Sep 1, 2016 | Apr 30, 2018 | May 22, 2018 | 1 | Canada |
The safety and tolerability of IONIS- APOC-III-LRx will be assessed by determining the incidence, severity, and dose relationship of adverse effects and changes in the laboratory parameters by dose. Safety results in subjects dosed with IONIS APOC-III-LRx will be compared with those from subjects dosed with placebo.
| Arm | Type | Description |
|---|---|---|
| IONIS-APOC-III-LRx | EXPERIMENTAL | Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection |
| Placebo (Normal Saline) | PLACEBO_COMPARATOR | Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator |
| Name | Type | Description |
|---|---|---|
| APOC-III-L-Rx | DRUG | Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection |
| Placebo Comparator | DRUG | Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator |
Inclusion Criteria: * Must have given written informed consent and be able to comply with all study requirements * Healthy males or females aged 18-65 inclusive * Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal * Males must be surgically sterile, ab...