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ch-mAb7f9

Phase 1

Methamphetamine Abuse | Monoclonal antibody | Other |cbdMD, Inc.|Last Updated: May 13, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

ch-mAb7f9 · 1 trial · 1 indication

Phase 1 1
NCT01603147Safety Study of Ch-mAb7F9 for Methamphetamine AbuseMethamphetamine Abuse
COMPLETED42 Analytics
PHASE1COMPLETED
Safety Study of Ch-mAb7F9 for Methamphetamine Abuse
Methamphetamine AbuseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
21 weeks

The primary outcome is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.

Secondary Endpoints

Pharmacokinetics
21 weeks
Immunogenicity
21 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SalinePLACEBO_COMPARATORA total of 10 subjects will receive placebo
ch-mAb7F9EXPERIMENTALThe single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively.

Interventions

NameTypeDescription
normal salineBIOLOGICALsaline 225 ml
ch-mAb7f9BIOLOGICALThe single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. Volume to be administered 225 ml
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects with the following criteria may be considered for inclusion in the study: 1. Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent form prior to performing any of the screening procedures. 2. Healthy, determined by the PI ba...

Countries:United States
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Frequently asked questions about ch-mAb7f9

What is ch-mAb7f9 used for?

ch-mAb7f9 is an investigational monoclonal antibody being developed for methamphetamine abuse. It is intended to treat this condition, and it is currently in Phase 1 clinical development. The drug is being studied in a completed Phase 1 trial that evaluated its safety in participants with methamphetamine abuse.

Who makes ch-mAb7f9?

ch-mAb7f9 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is advancing this monoclonal antibody through clinical development for methamphetamine abuse.

What phase is ch-mAb7f9 in?

ch-mAb7f9 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for methamphetamine abuse.

What clinical trials is ch-mAb7f9 in?

ch-mAb7f9 has one completed Phase 1 clinical trial, identified as NCT01603147, titled 'Safety Study of Ch-mAb7F9 for Methamphetamine Abuse.' This trial enrolled 42 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is ch-mAb7f9 the same as Ch-mAb7F9?

Yes, ch-mAb7f9 is the same drug as Ch-mAb7F9. The name appears in different capitalizations in clinical trial records, but both refer to the same investigational monoclonal antibody being developed for methamphetamine abuse.