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HCXT-2001

Phase 1

Psoriasis | Small molecule | Dermatology |cbdMD, Inc.|Last Updated: Aug 28, 2026

Target and mechanism

ModalitySmall molecule

Also known as HCXT-2001 Tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

HCXT-2001 · 1 trial · 1 indication

Phase 1 1
NCT07792928A Phase 1 Study to Evaluate the Safety and Effects of a Single Dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Adults.Psoriasis
NOT YET_RECRUITING40 Analytics
PHASE1NOT YET_RECRUITING
A Phase 1 Study to Evaluate the Safety and Effects of a Single Dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Adults.
Psoriasis
NCT0779292840
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Study Endpoints

Primary Endpoints

Number of participants with AEs,SEAs, with abnormal - vital signs,physcial examinations,clinical laboratory results ,12-lead ECGs and stool routine tests
Day 1 to Day 50

Secondary Endpoints

Maximum concentration of the drug (Cmax) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Day 1 to Day 50
Time to maximum concentration (Tmax) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Day 1 to Day 50
Area under the plasma concentration-time curve (AUC, including AUC0-t and AUC0-inf, etc.) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Day 1 to Day 50
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HCXT-2001 Tablets - Cohort 1EXPERIMENTAL -
HCXT-2001 Tablets - Cohort 2EXPERIMENTAL -
HCXT-2001 Tablets - Placebo Cohort 1PLACEBO_COMPARATOR -
HCXT-2001 Tablets(A) - Cohort 3EXPERIMENTAL -
HCXT-2001 Tablets(A) - Cohort 4EXPERIMENTAL -
HCXT-2001 Tablets(A) - Placebo Cohort 3PLACEBO_COMPARATOR -
HCXT-2001 Tablets - Placebo Cohort 2PLACEBO_COMPARATOR -
HCXT-2001 Tablets(A) - Placebo Cohort 4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
HCXT-2001 TabletsDRUGTwo tablets taken orally in a fasted state
PlaceboDRUGTwo tablets taken orally in a fasted state
HCXT-2001 Tablets(A)DRUGTwo tablets taken orally in a fasted state
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Body weight ≥ 50 kg for males and ≥ 45 kg for females, and body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening. 2. In good general health as determined by medical history, vital signs, physical examination, 12-lead ECG, laboratory tests (including hemat...

Countries:New Zealand
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Competitive Landscape -Psoriasis 49 trials

CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ9PHASE3JNJ-77242113
Bristol-Myers Squibb CompanyBMY14PHASE3BMS-986165
AbbVie, Inc.ABBV5PHASE3Risankizumab
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE3TAK-279
Alumis Inc.ALMS2PHASE3Open-Label Envudeucitinib, Blinded Envudeucitinib
Oruka Therapeutics, Inc.ORKA4PHASE2ORKA-001
Can-Fite Biopharma LtdCANF1PHASE3piclidenoson
Amgen Inc.AMGN1PHASE3Apremilast
Organon & Co.OGN1PHASE3tapinarof, 1%
Vanda Pharmaceuticals Inc.VNDA1PHASE3Ponesimod
Novartis AG Sponsored ADRNVS3 - Undisclosed
Bausch Health Companies Inc.BHC2 - Brodalumab, Matched cohort
Genelux Corp.GNLX1N/AHPP737
Sage BionetworksSAGE1 - Undisclosed
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