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Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer

NCT01870037 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-05-08

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety of a single treatment of hMaxi-K compared to placebo (PBS-20% sucrose) administered by direct bladder wall injections. Two dose levels (16000 µg and 24000 µg; 20 or 30 bladder wall injections, respectively) in females with moderate Overactive Bladder/Detrusor overactivity (OAB/DO) of ≥6 months duration will be evaluated. In each dose level, 6 participants will receive hMaxi-K and 3 will receive placebo.

Conditions

Interventions

DRUG

Placebo (PBS-20% sucrose)

DRUG

hMaxi-K

Single treatment/2 escalating dose levels (16000 µg and 24000 µg by intramuscular injection)

Sponsors & Collaborators

  • Ion Channel Innovations

    collaborator INDUSTRY

  • Urovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-06-30
Completion
2018-02-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01870037 on ClinicalTrials.gov