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single dose

Phase 1

Hypertension (HTN) | Unknown | Cardiovascular |cbdMD, Inc.|Last Updated: Apr 14, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

single dose · 1 trial · 1 indication

Phase 1 1
NCT07529600A Phase I Clinical Study of ART101 Injection in Healthy Adult SubjectsHypertension (HTN)
COMPLETED40 Analytics
PHASE1COMPLETED
A Phase I Clinical Study of ART101 Injection in Healthy Adult Subjects
Hypertension (HTN)Unlock trial analytics

Study Endpoints

Primary Endpoints

Assess safety of ART101 by the incidence of adverse events, adverse events of special interest and SAEs
Up to Day 169 post first dose administration
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Up to Day 169 post first dose administration

Fasting serum chemistry, fasting hematology, fasting coagulation, fasting LFTs, fasting lipid panel, fasting glycemic assessment, urinalysis will be assessed.

Secondary Endpoints

Serum PK Parameters: Maximum Concentration (Cmax)
Samples will be collected at 11 timepoints ,including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Concentration change in pharmacodynamics of ART101 by noting change from baseline of serum angiotensinogen.
Day -2 pre dosing, day 1, day 3, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 (~3 Months), Day 127, Day 169 (6 Months), post first dose administration.
Urine PK Parameters:Renal Clearance (Ae)
Urine will be collected between 1 hour to 0 hour pre dosing, 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours post dosing.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
25mgOTHERSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo
75mgOTHERSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo
150mgOTHERSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo
300 mgOTHERSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo
600 mgOTHERSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo

Interventions

NameTypeDescription
Subcutaneous (SC) single doseDRUGall administered via subcutaneous injection.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * 1\. Aged 18 to 60 years (inclusive) at the time of signing the informed consent form (ICF), male or female. 2\. Generally good health, with no clinically significant abnormalities in vital signs, physical examination, laboratory tests, or 12-lead ECG results at screening. ...

Countries:China
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Frequently asked questions about single dose

What is single dose used for?

Single dose is an investigational drug being studied for the treatment of hypertension (HTN). It is currently in Phase 1 clinical development, with a completed trial evaluating its safety and tolerability in healthy adult subjects.

Who makes single dose?

Single dose is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this investigational drug for hypertension.

What phase is single dose in?

Single dose is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under study for hypertension.

What clinical trials is single dose in?

Single dose has one completed clinical trial, identified as NCT07529600, titled "A Phase I Clinical Study of ART101 Injection in Healthy Adult Subjects." This trial enrolled 40 participants in China and evaluated the drug in healthy volunteers.

Is single dose the same as ART101?

Yes, single dose is also known as ART101. The completed Phase 1 clinical trial for this drug is titled "A Phase I Clinical Study of ART101 Injection in Healthy Adult Subjects," confirming that ART101 is the alternative name for single dose.