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HTD4010

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |cbdMD, Inc.|Last Updated: Aug 11, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

HTD4010 · 1 trial · 1 indication

Phase 1 1
NCT02538848Study of HTD4010 in Healthy VolunteersType 2 Diabetes Mellitus
COMPLETED32 Analytics
PHASE1COMPLETED
Study of HTD4010 in Healthy Volunteers
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence, severity and causality of adverse events
One day in SAD
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
50mg in SADEXPERIMENTALsingle dose of 50mg HTD4010 or placebo injectable in healthy volunteers
100mg in SADEXPERIMENTALsingle dose of 100mg HTD4010 or placebo injectable in healthy volunteers
200mg in SADEXPERIMENTALsingle dose of 200mg HTD4010 or placebo injectable in healthy volunteers
300mg in SADEXPERIMENTALsingle dose of 300mg HTD4010 or placebo injectable in healthy volunteers

Interventions

NameTypeDescription
HTD4010DRUGinjectable solution
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

For volunteers in SAD: Inclusion Criteria: 1. Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2 2. Non-diabetic, fasting plasma glucose \< 5.6 mmol/L 3. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral ...

Countries:Australia
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Frequently asked questions about HTD4010

What is HTD4010 used for?

HTD4010 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential role in managing this metabolic condition.

Who makes HTD4010?

HTD4010 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is advancing this small molecule through clinical development for Type 2 Diabetes Mellitus.

What phase is HTD4010 in?

HTD4010 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for Type 2 Diabetes Mellitus.

What clinical trials is HTD4010 in?

HTD4010 has one completed Phase 1 clinical trial, identified as NCT02538848, titled "Study of HTD4010 in Healthy Volunteers." This randomized, double-blind, controlled study enrolled 32 participants in Australia and included healthy volunteers aged 18 years and older.

Is HTD4010 FDA approved?

HTD4010 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 2 Diabetes Mellitus. The completed Phase 1 trial was conducted in healthy volunteers, and the drug has not yet progressed to later-stage trials or received regulatory approval.