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ION547

Phase 1

Healthy Volunteers | Small molecule | Other |Ionis Pharmaceuticals, Inc.|Last Updated: Sep 23, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

ION547 · 1 trial · 1 indication

Phase 1 1
NCT04934891A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION547Healthy Volunteers
COMPLETED48 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION547
Healthy Volunteers
NCT0493489148
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Study Endpoints

Primary Endpoints

Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Up to Day 232
Cmax: Maximum Observed Plasma Concentration of ION547
Up to Day 232
Tmax: Time Taken to Reach Maximal Plasma Concentration of ION547
Up to Day 232
AUCt: Area Under the Plasma Concentration-time Curve From Time Zero to Time t for ION547
Up to Day 232
Urine 0-24 Hour (hr) Excretion of ION547
Up to 24 hours
Change from Baseline in FXII Antigen Levels
Up to Day 232
Change from Baseline in FXII Activity Levels
Up to Day 232
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ION547EXPERIMENTALAscending single multiple doses of ION547 will be administered by SC injection.
PlaceboPLACEBO_COMPARATORAscending single multiple doses of ION547-matching placebo will be administered by SC injection.

Interventions

NameTypeDescription
ION547DRUGION547 will be administered by SC injection.
PlaceboDRUGION547-matching placebo will be administered by SC injection.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements. 2. Healthy males or females 18 to 65, inclusive, at the time of informed consent. 3. Satisfy the following: a. Femal...

Countries:Canada
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Frequently asked questions about ION547

What is ION547 used for?

ION547 is an investigational small molecule being developed by Ionis Pharmaceuticals for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies focused on assessing its safety, tolerability, pharmacokinetics, and pharmacodynamics in this population.

Who makes ION547?

ION547 is developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the drug's safety and other properties in healthy volunteers.

What phase is ION547 in?

ION547 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ION547 in healthy volunteers.

What clinical trials is ION547 in?

ION547 has one completed Phase 1 clinical trial, identified as NCT04934891. This study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ION547 in healthy volunteers in Canada.

Is ION547 FDA approved?

ION547 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, meaning it has not yet been evaluated in later-stage trials or submitted for regulatory approval.

Is ION547 a small molecule?

Yes, ION547 is a small molecule therapeutic. It is being developed by Ionis Pharmaceuticals and is currently in Phase 1 clinical trials to evaluate its safety and other properties in healthy volunteers.