Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IONIS FXI-LRx · 1 trial · 1 indication
| 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...
IONIS FXI-LRx is an investigational small molecule developed by Ionis Pharmaceuticals, Inc. (ticker IONS). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. No approved indication has been announced for this asset.
IONIS FXI-LRx is being developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IONS. Ionis is the sponsor of the clinical program for this investigational small molecule.
IONIS FXI-LRx is in Phase 1 development. Its only recorded clinical trial, NCT03582462, is a completed Phase 1 study. The drug is investigational and has not been approved by the FDA for any indication.
IONIS FXI-LRx has been evaluated in one clinical trial, NCT03582462, titled a study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of IONIS FXI-LRx in healthy volunteers. That Phase 1 trial is completed, enrolled 66 participants, and was conducted in Canada.
The Phase 1 trial of IONIS FXI-LRx, NCT03582462, was a randomized, double-blind, placebo-controlled study in healthy adult volunteers aged 18 years and older, including both sexes. It enrolled 66 participants and has been completed. The study assessed safety, tolerability, pharmacokinetics, and pharmacodynamics after single and multiple doses.