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IONIS FXI-LRx

Phase 1

Healthy Participants | Small molecule | Other |Ionis Pharmaceuticals, Inc.|Last Updated: Jan 18, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

IONIS FXI-LRx · 1 trial · 1 indication

Phase 1 1
NCT03582462A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of IONIS FXI-LRx in up to 84 Healthy VolunteersHealthy Participants
COMPLETED66 Analytics
PHASE1COMPLETED
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
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability as Measured by the Number of Participants with Treatment-Emergent Adverse Events
Up to 232 Days

Secondary Endpoints

Cmax: maximum observed drug concentration in plasma of IONIS FXI-LRx
Up to 232 Days
Tmax: time taken to reach maximal concentration in plasma of IONIS FXI-LRx
Up to 232 Days
AUC: area under the plasma concentration time curve for IONIS FXI-LRx
Up to 232 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IONIS FXI-LRxEXPERIMENTALAscending single and multiple doses of IONIS FXI-LRx by subcutaneous (SC) injection.
PlaceboPLACEBO_COMPARATORSterile Normal Saline (0.9% NaCl) calculated volume to match active comparator.

Interventions

NameTypeDescription
IONIS FXI-LRxDRUGAscending single and multiple doses of IONIS FXI-LRx by subcutaneous (SC) injection
PlaceboDRUGSterile Normal Saline (0.9% NaCl) calculated volume to match active comparator
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Canada
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Frequently asked questions about IONIS FXI-LRx

What is IONIS FXI-LRx used for?

IONIS FXI-LRx is an investigational drug being studied in healthy participants. It is being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in a clinical trial. The drug is in Phase 1 development and is not yet approved for any medical use.

Who makes IONIS FXI-LRx?

IONIS FXI-LRx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical research to assess the drug's properties in healthy volunteers.

What phase is IONIS FXI-LRx in?

IONIS FXI-LRx is in Phase 1 clinical development. A Phase 1 trial has been completed to evaluate the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is IONIS FXI-LRx in?

IONIS FXI-LRx has been studied in one clinical trial with the identifier NCT03582462. This completed Phase 1 study assessed single and multiple doses of the drug in up to 84 healthy volunteers in Canada. The trial enrolled 66 participants and was placebo-controlled and double-blind.

Is IONIS FXI-LRx the same as IONIS-FXI-LRx?

IONIS FXI-LRx is the drug name used in the clinical trial record. The trial title refers to the drug as IONIS FXI-LRx, and no other alternative names have been reported. The drug is being developed by Ionis Pharmaceuticals under this designation.