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OPL-002

Phase 1

Healthy | Small molecule | Other |Ventyx Biosciences, Inc.|Last Updated: May 28, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

OPL-002 · 1 trial · 1 indication

Phase 1 1
NCT04451811A PK Dose Proportionality Study of OPL-002 in Healthy VolunteersHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

AUC of OPL-002
0 to 48 hours

Secondary Endpoints

Dose proportionality of 5 and 20 mg
0 to 48 hours
Absolute lymphocyte count
0 to 48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
OPL-002 SDD 20 mgEXPERIMENTAL20 mg SDD formulation of OPL-002
OPL-002 5 mg TabletEXPERIMENTAL5 mg tablet formulation of OPL-002
OPL-002 20 mg TabletEXPERIMENTAL20 mg tablet formulation of OPL-002

Interventions

NameTypeDescription
OPL-002DRUGSpray dried dispersion and tablet formulation
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female (of non-childbearing potential only) between 18 and 55 years of age. * Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose...

Countries:United Kingdom
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Frequently asked questions about OPL-002

What is OPL-002 used for?

OPL-002 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its pharmacokinetics and dose proportionality. The drug is not approved for any indication and remains under investigation.

Who makes OPL-002?

OPL-002 is being developed by Ventyx Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker VTYX. The company is conducting early-stage clinical research on this small molecule in healthy volunteers.

What phase is OPL-002 in?

OPL-002 is in Phase 1 clinical development. A single Phase 1 study has been completed, involving 12 healthy volunteers in the United Kingdom. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is OPL-002 in?

OPL-002 has one completed clinical trial, NCT04451811, titled 'A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers.' This Phase 1 study enrolled 12 healthy adults aged 18 years and older in the United Kingdom and was a controlled, randomized trial.

Is OPL-002 FDA approved?

OPL-002 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial was a pharmacokinetic study in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory submission.