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ABP-745

Phase 1

Gout | Small molecule | Metabolic |cbdMD, Inc.|Last Updated: Aug 17, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

ABP-745 · 1 trial · 3 indications

Phase 1 1
NCT06258213A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy VolunteersGout
COMPLETED90 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (Safety and Tolerability)
Up to Day 14

Secondary Endpoints

Plasma pharmacokinetic parameters including peak plasma concentration (Cmax)
Up to Day 11
Urine pharmacokinetic parameters including amount excreted in urine over the sampling interval (Ae)
Up to Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
ABP-745ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ABP-745DRUG0.5, 5 or 25 mg tablet
PlaceboDRUGPlacebo tablet
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female volunteers, aged 18 and 55 years (inclusive) at the time of signing the informed consent form (ICF). * Body mass index (BMI) range within 18 \~ 30 kg/m2 (inclusive), and body weight of ≥ 50.0 kg for male and ≥ 45.0 kg for female. * Generally healthy base...

Countries:United States
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Frequently asked questions about ABP-745

What is ABP-745 used for?

ABP-745 is an investigational small molecule being developed for the treatment of gout, including acute gout flares. It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy volunteers.

Who makes ABP-745?

ABP-745 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The drug is currently in Phase 1 clinical development for the treatment of gout and gout flares.

What phase is ABP-745 in?

ABP-745 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study of the drug has been completed, evaluating its safety, tolerability, and pharmacokinetics in healthy volunteers.

What clinical trials is ABP-745 in?

ABP-745 has one completed Phase 1 clinical trial, identified as NCT06258213. This study evaluated the safety, tolerability, and pharmacokinetics of oral ABP-745 in healthy volunteers in the United States. The trial enrolled 90 participants and was randomized, double-blind, and placebo-controlled.

Is ABP-745 the same as any other drug?

ABP-745 is a distinct investigational drug candidate developed by cbdMD, Inc. It is not known to be the same as any other approved or marketed medication. It is being studied specifically for the treatment of gout and acute gout flares.