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CLZ-2002

Phase 1

Charcot Marie Tooth Disease, Type 1 | Small molecule | Other |cbdMD, Inc.|Last Updated: Feb 17, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

CLZ-2002 · 1 trial · 1 indication

Phase 1 1
NCT05947578The Safety and Tolerability of CLZ-2002 in Patients With Charcot-Marie Tooth Disease.Charcot Marie Tooth Disease, Type 1
COMPLETED9 Analytics
PHASE1COMPLETED
The Safety and Tolerability of CLZ-2002 in Patients With Charcot-Marie Tooth Disease.
Charcot Marie Tooth Disease, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of intramuscular (IM) injections of CLZ-2002 in Participants
Day 1 (visit 2) to Week 24 (visit 6)

Frequency and percentage of treatment-emergent adverse events (TEAEs) and serious adverse events after injection through laboratory tests, physical examinations, vital signs, and electrocardiogram measurements conducted during the clinical trial.

Secondary Endpoints

Changes from baseline in the disease severity of CMTNS-v2 score at Weeks 4, 12, and 24.
Weeks 4, 12 and 24
Changes from baseline in neurological examination at Weeks 1, 4, 12 and 24
Weeks 1, 4, 12 and 24
Changes from baseline in the overall neuropathy limitation scale (ONLS) at Weeks 4, 12 and 24
Weeks 4, 12 and 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CLZ-2002EXPERIMENTALCLZ-2002 injection is intramuscular in lower limbs on Day 1.

Interventions

NameTypeDescription
CLZ-2002DRUGLow dose group (6×10\^6 cells), Mid dose group (12×10\^6 cells), High dose group (24×10\^6 cells)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects aged 18 years or older * Subjects with a proven diagnosis of Charcot-Marie-Tooth disease type 1 at the time of screening visit * Subjects who have muscle weakness in at least foot dorsiflexion (clinical assessment) at the time of screening visit * Subjects with a CMT ...

Countries:South Korea
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Frequently asked questions about CLZ-2002

What is CLZ-2002 used for?

CLZ-2002 is an investigational small molecule being developed for the treatment of Charcot Marie Tooth Disease, Type 1. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes CLZ-2002?

CLZ-2002 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The drug is in Phase 1 clinical development for Charcot Marie Tooth Disease, Type 1.

What phase is CLZ-2002 in?

CLZ-2002 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received regulatory approval for any indication.

What clinical trials is CLZ-2002 in?

CLZ-2002 has one completed Phase 1 clinical trial, identified as NCT05947578, titled "The Safety and Tolerability of CLZ-2002 in Patients With Charcot-Marie Tooth Disease." The trial enrolled 9 participants in South Korea and was not randomized or blinded.

Is CLZ-2002 FDA approved?

CLZ-2002 is not FDA approved. It is an investigational drug in Phase 1 clinical development for Charcot Marie Tooth Disease, Type 1. The completed Phase 1 trial focused on safety and tolerability.