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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02414594 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS APO(a)-LRx in Healthy Volunteers With Elevated Lipoprotein(a) | PHASE1 | COMPLETED | 60 | — | — | Apr 1, 2015 | Feb 1, 2016 | Dec 5, 2018 | 1 | Canada |
The safety and tolerability of IONIS-APO(a)-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-APO(a)-LRx will be compared with those from subjects dosed with placebo.
The plasma pharmacokinetics of IONIS-APO(a)-LRx (unconjugated and conjugated ASO) will be assessed following single and multiple-dose SC administration. The amount of ISIS-APO(a)-LRx excreted in urine at selected 24-hour intervals will also be determined.
Changes in plasma Lp(a) levels compared to baseline.
| Arm | Type | Description |
|---|---|---|
| IONIS-APO(a)-LRx | EXPERIMENTAL | Drug: IONIS-APO(a)-LRx |
| Placebo (Normal Saline) | PLACEBO_COMPARATOR | Drug: Sterile Normal Saline (0.9% NaCl) |
| Name | Type | Description |
|---|---|---|
| IONIS-APO(a)-LRx | DRUG | Ascending single and multiple doses of IONIS-APO(a)-LRx by subcutaneous (SC) injection |
| Sterile Normal Saline (0.9% NaCl) | DRUG | 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 and weighing ≥ 50 kg at the time of informed consent * Females must be non-pregnant and non-lactating, and either surgically sterile or po...