Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
hMaxi-K · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo (PBS-20% sucrose) | PLACEBO_COMPARATOR | PBS-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 µg | EXPERIMENTAL | Single treatment (16000 µg by 20 intramuscular injections). A total of 6 participants will receive hMaxi-K, and 3 will receive placebo. |
| hMaxi-K 24000 µg | EXPERIMENTAL | Single treatment (24000 µg by 30 intramuscular injections). A total of 6 participants will receive hMaxi-K, and 3 will receive placebo. |
| Name | Type | Description |
|---|---|---|
| Placebo (PBS-20% sucrose) | DRUG | - |
| hMaxi-K | DRUG | Single treatment/2 escalating dose levels (16000 µg and 24000 µg by intramuscular injection) |
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...
hMaxi-K is an investigational small molecule being developed for the treatment of overactive bladder. It is currently in Phase 1 clinical development and has completed one clinical trial in the United States.
hMaxi-K is a gene transfer therapy that delivers the gene for the large-conductance calcium-activated potassium channel, also known as Maxi-K or BK channel. This channel helps regulate smooth muscle contraction, which is relevant to overactive bladder.
hMaxi-K is being developed by Channel Therapeutics Corporation, a biopharmaceutical company. The company is publicly traded under the ticker symbol PTHS.
hMaxi-K is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and not yet approved.
hMaxi-K has been studied in one completed clinical trial, NCT01870037, titled 'Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer.' This trial enrolled 13 female participants with overactive bladder in the United States.
hMaxi-K is a gene transfer therapy that delivers the gene for the Maxi-K potassium channel. It is sometimes referred to by the name hMaxi-K, which stands for human Maxi-K. The drug itself is distinct from the endogenous channel it encodes.