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ABP-671

Phase 1

Gout | Small molecule | Metabolic |cbdMD, Inc.|Last Updated: Jul 29, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

ABP-671 · 1 trial · 2 indications

Phase 1 1
NCT03906006A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy SubjectsGout
COMPLETED32 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects
GoutUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
baseline to 7 days
Maximum tolerable dose
baseline to 7 days

Secondary Endpoints

Peak plasma concentration
baseline to 72 hours
half-life
baseline to 72 hours
area under the curve
baseline to 72 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABP-671, Cohort 1-EXPERIMENTALABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 2-EXPERIMENTALABP-671, Cohort 2 participants will receive 0.1 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 3-EXPERIMENTALABP-671, Cohort 3 participants will receive 0.5 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 4-EXPERIMENTALABP-671, Cohort 4 participants will receive 1.0 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).

Interventions

NameTypeDescription
ABP-671DRUGDrug: ABP-671, single oral dose
PlaceboOTHEROther: Placebo, single oral dose
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria 1. Healthy (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, and vital signs. 2. Participants serum uric acid level at screening ≥ 4.0 mg/dL to ≤ 5.5 mg/dL for males, and ≥ 4.0 mg/dL to ≤ 5.0 mg/dL for females. 3. Pa...

Countries:United States
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Frequently asked questions about ABP-671

What is ABP-671 used for?

ABP-671 is an investigational small molecule being developed for the treatment of gout, a metabolic condition characterized by elevated uric acid levels. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ABP-671?

ABP-671 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The drug is in early-stage clinical development for gout.

What phase is ABP-671 in?

ABP-671 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Its Phase 1 trial has been completed.

What clinical trials is ABP-671 in?

ABP-671 has one completed Phase 1 clinical trial, identified as NCT03906006. This study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABP-671 in healthy subjects with gout or hyperuricemia. The trial enrolled 32 participants in the United States.

Is ABP-671 the same as any other drug?

No alternative names for ABP-671 have been disclosed. It is identified solely by its development code, ABP-671, in clinical trial registries and company communications.