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hMaxi-K

Phase 1

Overactive Bladder | Small molecule | Nephrology |Channel Therapeutics Corporation|Last Updated: May 8, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01870037Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene TransferPHASE1 COMPLETED 13 — — Jan 1, 2013Feb 17, 2018May 8, 20193 United States
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Study Endpoints
Primary Endpoints
Number of participants with any treatment-emergent adverse event during the Treatment Period
6 months (24 weeks) per participant
Number of participants with any treatment-emergent adverse event during the Safety Follow-up Period
18 months
Number of participants with any clinically significant clinical laboratory test value during the Treatment Period
6 months (24 weeks) per participant
Number of participants with any clinically significant clinical laboratory test value during the Safety Follow-up Period
18 months
Number of participants with any clinically significant electrocardiogram finding during the Treatment Period
6 months (24 weeks) per participant
Number of participants with any clinically significant electrocardiogram finding during the Safety Follow-up Period
18 months
Number of participants with any clinically significant physical examination finding during the Treatment Period
6 months (24 weeks) per participant
Number of participants with any clinically significant physical examination finding during the Safety Follow-up Period
18 months
Secondary Endpoints
Change from Baseline in the number of micturitions per day
Baseline; 6 months (24 weeks) per participant
Change from Baseline in the volume of micturitions
Baseline; 6 months (24 weeks) per participant
Change from Baseline in incontinence episodes
Baseline; 6 months (24 weeks) per participant
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Placebo (PBS-20% sucrose)PLACEBO_COMPARATORPBS-20% sucrose administered during two single-treatment dose levels (16000 micrograms \[µg\] and 24000 µg) by direct bladder wall intramuscular injections, 20 to 30 injections depending on active dose comparator.
hMaxi-K 16000 µgEXPERIMENTALSingle treatment (16000 µg by 20 intramuscular injections). A total of 6 participants will receive hMaxi-K, and 3 will receive placebo.
hMaxi-K 24000 µgEXPERIMENTALSingle treatment (24000 µg by 30 intramuscular injections). A total of 6 participants will receive hMaxi-K, and 3 will receive placebo.
Interventions
NameTypeDescription
Placebo (PBS-20% sucrose)DRUG -
hMaxi-KDRUGSingle treatment/2 escalating dose levels (16000 µg and 24000 µg by intramuscular injection)
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Healthy women of ≥18 years of age and non-childbearing potential 2. Symptoms of overactive bladder for ≥6 months including at least one of the following: 1. Frequent micturition ≥8 times per 24 hours 2. Urinary urgency or nocturia 3. Urge urinary incontinence five o...

Countries:United States
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