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ATB-346 low dose

Phase 2

Osteoarthritis | Small molecule | Musculoskeletal |cbdMD, Inc.|Last Updated: Jul 21, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment381

FDA Designations

No designations recorded

Clinical trial landscape

ATB-346 low dose · 1 trial · 1 indication

Phase 2 1
NCT03978208Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis PatientsOsteoarthritis
COMPLETED381 Analytics
PHASE2COMPLETED
Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

5-item pain intensity measure
Previous 48 hours

Self reported pain intensity over the past 48 hours. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total between 0 and 50

Secondary Endpoints

2-item stiffness intensity measure
Previous 48 hours
17-item difficulty performing daily activities measure
Previous 48 hours
Measurement of whole blood cyclo-oxygenase activity
After 1, 4 and 14 days of treatment dosing.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo ComparatorACTIVE_COMPARATORATB-346 150 mg overencapsulated tablet taken by mouth once daily for 14 days
ATB-346 mid-doseACTIVE_COMPARATORATB-346 200 mg overencapsulated tablet taken by mouth once daily for 14 days
ATB-346 standard doseACTIVE_COMPARATORATB-346 250 mg overencapsulated tablet taken by mouth once daily for 14 days
Active ComparatorPLACEBO_COMPARATOROverencapsulated placebo tablet taken by mouth once daily for 14 days

Interventions

NameTypeDescription
ATB-346 low doseDRUGDouble blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
PlaceboOTHERDouble blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
ATB-346 mid-doseDRUGDouble blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
ATB-346 standard doseDRUGDouble blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Diagnosis greater than 2 years duration requiring the use of regular therapies, e.g. oral or topical anti-inflammatories, acetaminophen, topical capsaicin * Between the ages of 40 to 75 * BMI ≤40 * Patients must be unlikely to procreate or agree to the use of acceptable contra...

Countries:Canada
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Frequently asked questions about ATB-346 low dose

What is ATB-346 low dose used for?

ATB-346 low dose is an investigational small molecule being studied for the treatment of osteoarthritis, a degenerative joint disease. It is being developed by cbdMD, Inc. (ticker: YCBD). The drug is currently in Phase 2 clinical development for this indication.

Who makes ATB-346 low dose?

ATB-346 low dose is being developed by cbdMD, Inc., a company traded on the stock market under the ticker YCBD. The company is conducting clinical research to evaluate the drug's efficacy and safety in patients with osteoarthritis.

What phase is ATB-346 low dose in?

ATB-346 low dose is in Phase 2 clinical development. A Phase 2 trial has been completed, which was a randomized, double-blind, placebo-controlled study involving 381 participants with osteoarthritis. The drug is not yet approved and remains investigational.

What clinical trials is ATB-346 low dose in?

ATB-346 low dose has one completed clinical trial, identified as NCT03978208, titled "Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients." This Phase 2 study enrolled 381 participants in Canada and was randomized, double-blind, and placebo-controlled.

Is ATB-346 low dose FDA approved?

ATB-346 low dose is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for osteoarthritis. A Phase 2 trial has been completed, but the drug has not yet received regulatory approval for any use.