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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03582462 | A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of IONIS FXI-LRx in up to 84 Healthy Volunteers | PHASE1 | COMPLETED | 66 | — | — | Jul 9, 2018 | Apr 26, 2019 | Jan 18, 2022 | 1 | Canada |
| Arm | Type | Description |
|---|---|---|
| IONIS FXI-LRx | EXPERIMENTAL | Ascending single and multiple doses of IONIS FXI-LRx by subcutaneous (SC) injection. |
| Placebo | PLACEBO_COMPARATOR | Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator. |
| Name | Type | Description |
|---|---|---|
| IONIS FXI-LRx | DRUG | Ascending single and multiple doses of IONIS FXI-LRx by subcutaneous (SC) injection |
| Placebo | DRUG | Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator |
Inclusion Criteria * Body mass index (BMI) ≤ 35 kg/m2 * Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal * Males must be surgically sterile, abstinent or, if engaged in sexual relations with a female of child-bearing potential, the subject must be usi...