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GV-100

Phase 1

ADPKD (Autosomal Dominant Polycystic Kidney Disease) | Small molecule | Nephrology |cbdMD, Inc.|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

GV-100 · 1 trial · 1 indication

Phase 1 1
NCT07788014A Phase 1 Study of Single and Multiple Ascending Doses of GV-100ADPKD (Autosomal Dominant Polycystic Kidney Disease)
RECRUITING80 Analytics
PHASE1RECRUITING
A Phase 1 Study of Single and Multiple Ascending Doses of GV-100
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
NCT0778801480
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Study Endpoints

Primary Endpoints

Adverse event
Up to 7 weeks

Secondary Endpoints

Maximum plasma concentration (Cmax) of GV-100
Part 1: From Day 1 to Day 2 Part 2: From Day 1 to Day 15 Part 3: From Day 1 to Day 9 Part 4: From Day 1 to Day 15
Area under the plasma concentration time curve (AUC) of GV-100
Part 1: From Day 1 to Day 2 Part 2: From Day 1 to Day 15 Part 3: From Day 1 to Day 9 Part 4: From Day 1 to Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GV-100EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
GV-100DRUGGV-100 will be administered orally
PlaceboDRUGMatched to GV-100
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time of providing informed consent, who are non-smokers (no use of tobacco or nicotine-containing products within 3 months prior to screening), with a body mass index (BMI) greater...

Countries:Australia
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