Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene for ED
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection); Placebo (PBS-20% sucrose)
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ED

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible participants must meet the following inclusion criteria:

               1. Signed Informed Consent

               2. Be adult males over 18 years of age diagnosed with erectile dysfunction and whose
                  ED is attributable to an underlying, stable medical condition such as
                  hypertension and atherosclerosis, antihypertensive medication, type I and type II
                  diabetes mellitus, pelvic surgery and pelvic radiation, cerebrovascular accidents
                  (stroke), multiple sclerosis, and Parkinson's disease;

               3. Participants must have been unable to have successful sexual intercourse for 3
                  months prior to study entry without specific ED therapy such as Vacuum Erection
                  device (VED), ViagraTM (sildenafil), Cialis TM (tadalafil), MuseTM (alprostadil),
                  or intracavernous injection therapy with an erectile function domain score of
                  IIEF<21 at screening and baseline;

               4. Have been unable to tolerate, do not wish to continue, or have had unsuccessful
                  results with, prior therapy for ED, e.g., ViagraTM, intracavernous injection
                  therapy, MuseTM, or VED;

               5. If diabetic, documentation of HgA1c less than or equal to 8.0% prior to
                  enrollment;

               6. If receiving medication for hypertension, documentation of blood pressure has
                  been stable on the same medication for at least 2 months prior to enrollment;

               7. Be heterosexual and in a stable, monogamous relationship of at least six months
                  duration;

               8. Agree to attempt intercourse with their partner at least four times per month
                  while participating in the study;

               9. Agree not to use other treatments for ED while participating in this study;

              10. Have screening laboratory values and ECG that are within the normal range. See
                  exclusion criterion below.

              11. A prior penile prosthetic implant;

              12. Have a normal physical examination of the penis;

              13. If participant had a radical prostatectomy a PSA <0.4 for at least one year
                  documented by 2 measurements during the preceding year;

              14. Be literate, able to give written informed consent, and comply with all study
                  procedures and requirements.

        Exclusion Criteria:

          1. A history of sickle-cell disease, sickle cell trait, or any other medical condition
             that, in the judgment of the investigator, would contraindicate the administration of
             study medication or interfere with the study evaluations;

          2. In the judgment of the investigator any condition that would interfere with
             participation in the study (including geographical inaccessibility), that would
             contraindicate the administration of study medication or interfere with the study
             evaluations.

          3. Had within six months prior to enrollment any of the following:

               -  Myocardial infarction

               -  Cerebrovascular accident

               -  Uncontrolled hypertension (systolic >160 or diastolic >100mmHg)

               -  Arrhythmia

               -  Congestive heart failure (dyspnea on minimal exertion or while supine)

               -  Unstable angina (chest pain greater than three times weekly while on therapy)

               -  Required treatment with calcium channel, beta-blocker medication, nitrates, or
                  anti-epileptic drugs;

          4. Poorly controlled diabetes mellitus as defined by HgA1c > 8.0 mg% at time of
             enrollment;

          5. Change in medication for diabetes or hypertension within 2 months of study enrollment;

          6. Gonadal failure (testosterone < 200 ng/dl) not treated with hormone replacement;

          7. History of malignancy except non-melanomatous skin cancers;

          8. A life expectancy of less than 12 months;

          9. An indwelling urethral catheter;

         10. A prior penile prosthetic implant;

         11. Received an investigational drug, investigational therapy, or other form of ED
             therapy, including approved treatments, within the past 30 days;

         12. Peyronie's disease;

         13. Any screening laboratory values outside of the normal laboratory range as defined by
             the central laboratory normal ranges and in the judgment of the investigator is
             considered clinically significant (hepatic biochemical markers [AST, ALT, GGT,
             alkaline phosphatase, and bilirubin] > twice the upper limit of the normal reference
             range may be accepted with written consent of the sponsor).

         14. Any clinically significant ECG abnormality

        NOTE: Sinus bradycardia of 50-59 bpm is permissible. Other abnormalities that can be normal
        variants (and considered clinically insignificant) may be permissible. However,
        participants with such abnormalities cannot be randomized without review of their medical
        history and prior written approval of the sponsor (or designee).