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ION547

Phase 1

Undisclosed | Small molecule | Other |Ionis Pharmaceuticals, Inc.|Trials Updated: Sep 23, 2022

ION547 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2021

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

ION547 clinical trials

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 VolunteersUnlock trial analytics

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?

ION547 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. Ionis has not publicly disclosed the specific disease or condition that ION547 is intended to treat.

Who makes ION547?

ION547 is being developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IONS. Ionis is the sponsor of the clinical program evaluating ION547.

What phase is ION547 in?

ION547 is in Phase 1 clinical development. Its single Phase 1 trial, NCT04934891, has been completed. Because no later-stage trials have been reported, ION547 remains an investigational drug and has not been approved by the FDA for any indication.

What clinical trials is ION547 in?

ION547 has been evaluated in one Phase 1 trial, NCT04934891, titled "A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION547." The trial enrolled 48 healthy adult volunteers in Canada and is now completed.

How was the Phase 1 trial of ION547 designed?

The Phase 1 trial NCT04934891 was a randomized, double-blind, placebo-controlled study of single and multiple doses of ION547. It enrolled 48 healthy volunteers of any sex, aged 18 years and older, at sites in Canada, and assessed safety, tolerability, pharmacokinetics, and pharmacodynamics.

What is ION547 used for?

ION547 is an investigational drug, and the condition it is intended to treat has not been disclosed. Its only reported clinical study was a Phase 1 trial in healthy volunteers, which evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics rather than efficacy in a patient population.