Recent Updates
Recently added Catalysts

OPL-002

Phase 2

Undisclosed | Small molecule | Other |Ventyx Biosciences, Inc.|Trials Updated: May 28, 2021

OPL-002 development status

Highest phase Phase 2 (NCT05156125)
Phase scored for VTYXPhase 1
Registered trials 2 across 1 sponsor since Jun 2020

OPL-002 target and mechanism

ModalitySmall molecule

Also known as VTX002

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

OPL-002 clinical trials

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
HealthyUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about OPL-002

What is OPL-002?

OPL-002 is an investigational small molecule developed by Ventyx Biosciences, Inc. (ticker VTYX). It is in Phase 1 clinical development, and its specific therapeutic indications have not been disclosed. The program has completed one Phase 1 pharmacokinetic study in healthy volunteers.

Who is developing OPL-002?

OPL-002 is being developed by Ventyx Biosciences, Inc., which trades on the Nasdaq under the ticker VTYX. The company is the sponsor of the clinical program for this small molecule asset.

What phase is OPL-002 in?

OPL-002 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is OPL-002 in?

OPL-002 has been evaluated in one completed Phase 1 trial, NCT04451811, titled A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers. The study enrolled 12 healthy adult participants in the United Kingdom and used a controlled, randomized design without blinding.

What was studied in the OPL-002 Phase 1 trial?

The completed Phase 1 trial NCT04451811 evaluated the pharmacokinetic dose proportionality of OPL-002 in healthy volunteers. It enrolled 12 participants aged 18 years and older of all sexes in the United Kingdom. The study was randomized and controlled, and it has been completed.