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Doxorubicin-containing MNA

Phase 1

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

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

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 Carcinoma
NCT0492822225
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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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