Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene for ED
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of a single intracavernous injection of hMaxi K (8000 µg
      and 16000 µg) or placebo upon penile rigidity or erection in males with erectile dysfunction
      longer than six months that is attributable to an underlying, stable medical condition.
    

Detailed description: 
      This study is a double-blind, placebo controlled, parallel design, Phase 2A study evaluating
      the potential activity and safety of a single administration of hMaxi-K (8000 or 16000 µg) or
      placebo (PBS sucrose 20%) injected into the corpus cavernosum of the penis in men who have
      been unable to tolerate, do not wish to continue, or have had unsuccessful results with,
      prior therapy for ED.

      The study population is men with erectile dysfunction attributable to an underlying, stable
      medical condition but who are otherwise in good health. The target population is men with
      erectile dysfunction and those who have been unable to tolerate, do not wish to continue, or
      have had unsuccessful results with, prior therapy for ED and with an erectile function domain
      score of IIEF < 21 at screening and baseline.

      Following screening and study drug administration at Week 0 (Visit 2 [V2]), eligible
      participants will be evaluated at Weeks 1 (V3), 4 (V4), 8 (V5), 12 (V6), and 24 (V7). At each
      study visit, participants will have a physical examination including examination of the penis
      (all visits), vital signs, electrocardiogram (ECG) (all visits). Laboratory evaluations
      including chemistry and hematology will be done at V1, V3, V4, V6, and V7. Urinalysis will be
      done V1, V2 (prior to dosing), V3, V4, V6, and V7. Endocrine parameters and PTT, PT, sed rate
      and CRP will be evaluated at V1, V3, and V7. The participant will complete the erectile
      function domain of the IIEF and Sexual Encounter Profile (SEP) at screening/baseline and at
      V2, (SEP and IIEF at V2 prior to dosing) V3, V4, V5, V6, and V7. In all participants, plasma
      specimens will be collected to assay for the presence of hSlo DNA by PCR (V2-V7). These will
      be kept frozen at -20°C or less at the site for eventual assay by Sponsor.

      The primary efficacy outcome measures will include the Erectile Function (EF) domain of the
      International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), Questions 2
      and 3 from SEP. The IIEF EF domain has a 30-point total score, where higher scores reflect
      better erectile function. SEP is a diary in which participants record each sexual attempt
      made throughout the study. The two questions from the Sexual Encounter Profile (SEP) deal
      with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an
      erection long enough for successful intercourse (SEP3). The erectile function domain category
      of the IIEF will be used to evaluate the change in erectile status from baseline following
      administration of hMaxi-K. Change from baseline on the six questions of the IIEF's Erectile
      function domain category at every visit after administration of study drug will be calculated
      and compared among the two dose and one placebo groups.

      Safety will be assessed by analysis of adverse experiences, and abnormal findings on clinical
      laboratory tests, electrocardiogram, and physical examinations.

      6 months per participant (approximately 2 years to enroll all participants)

      A total of 35 participants were planned to be enrolled; N=11 on 8000 µg; N=11 on 16000 µg;
      N=13 on placebo.

      Both the safety data and data to assess activity will be presented as means and standard
      deviations or medians and ranges as appropriate for continuous data, and analyzed using
      either paired t- or Wilcox on Sign Rank tests for within group changes, and with mixed
      effects or marginal models to determine differences in trends among the three cohorts over
      time. Incidence of adverse events will be presented as relative frequencies within groups.
    

Intervention name(s): hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection); Placebo (PBS-20% sucrose)
Intervention type(s): Drug; Drug
Other intervention name(s): hMaxi-K; URO-902; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: ED