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Doxorubicin-containing MNA

Phase 1

Basal Cell Carcinoma | Small molecule | Oncology |Medicus Pharma Ltd.|Trials Updated: Apr 14, 2023

Doxorubicin-containing MNA development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Doxorubicin-containing MNA clinical trials

Doxorubicin-containing MNA · 1 trial · 1 indication

Phase 1 1
NCT04928222Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)Basal Cell Carcinoma
ACTIVE NOT_RECRUITING25 Analytics
PHASE1ACTIVE NOT_RECRUITING
Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)
Basal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of subjects with Eradication of Basal Cell Cancer based on Histologic Analysis
Up to 4 weeks after the last array application to a subject

Tissue will be excised and sectioned for histologic analysis

Number of subjects with dose-limiting toxicity and treatment-related adverse events by CTCAE v4.0
Assessment at week 2 of subject visit

Determination of cutaneous tolerability of arrays after application

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Doxorubicin-containing MNA - 100 µgACTIVE_COMPARATORA doxorubicin-containing array of 100 µg will be applied to subjects.
Placebo MNA for TrainingEXPERIMENTALTraining phase for application of arrays

Interventions

NameTypeDescription
Doxorubicin-containing MNACOMBINATION_PRODUCTA 15 x 15 millimeter array containing 400 dissolvable microneedles delivering active agent
Placebo-containing MNADRUGA 15 15 x 15 millimeter array containing 400 dissolvable microneedles containing placebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Adult males and females, 18+ years in general good health as assessed by the investigator. 2. Clinical laboratory results within the following ranges: 1. granulocytes ≥2,000/mm3 2. platelets \>50,000/mm3 3. serum creatinine ≤2X the upper limit of normal (ULN) 4. ...

Countries:United States
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Frequently asked questions about Doxorubicin-containing MNA

What is Doxorubicin-containing MNA?

Doxorubicin-containing MNA is an investigational small molecule therapy being developed by Medicus Pharma Ltd. for the treatment of basal cell carcinoma. It is a microneedle array product that delivers doxorubicin, a chemotherapy agent, directly into the skin. It is currently in Phase 1 clinical development.

What is Doxorubicin-containing MNA used for?

Doxorubicin-containing MNA is being developed for the treatment of basal cell carcinoma, a type of skin cancer. It is intended for topical administration via microneedles. The product is investigational and has not been approved for any indication.

Who is developing Doxorubicin-containing MNA?

Doxorubicin-containing MNA is being developed by Medicus Pharma Ltd., which trades under the ticker symbol MDCX. The company is responsible for the clinical development of this investigational therapy for basal cell carcinoma.

What phase is Doxorubicin-containing MNA in?

Doxorubicin-containing MNA is in Phase 1 clinical development. The ongoing trial is an active, randomized, double-blind, active-controlled study. It is not yet approved by the FDA or any regulatory agency.

What clinical trials is Doxorubicin-containing MNA in?

Doxorubicin-containing MNA is being evaluated in a Phase 1 trial, NCT04928222, titled 'Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II).' The trial is active but not recruiting, with an estimated enrollment of 25 participants in the United States.