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hMaxi-K

Phase 1

Overactive Bladder | Small molecule | Nephrology |Roivant Sciences Ltd.|Last Updated: May 8, 2019

Development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jul 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

hMaxi-K · 1 trial · 1 indication

Phase 1 1
NCT01870037Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene TransferOveractive Bladder
COMPLETED13 Analytics
PHASE1COMPLETED
Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer
Overactive Bladder
NCT0187003713
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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 to 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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