Injectable DMAU for Male Contraception in Healthy Male Volunteers (CCN015)

Inclusion Criteria: Men who meet all the following criteria are eligible for enrollment in the trial:

1. Male volunteers in good health as confirmed by physical examination, medical history,and clinical laboratory tests of blood and urine at the time of screening.
2. 18 to 50 years of age (inclusive) at the time of the enrollment visit.
3. BMI ≤ 33 calculated as weight in kg/ (height in m2).
4. Weight ≥60 kg.
5. No history of hormonal therapy use in the three months prior to the first screeningvisit.
6. Agree to use a recognized effective method of contraception with any female partner (i.e. at a minimum, barrier plus an additional method of contraception) during thecourse of the study treatment and recovery phases until recovery is confirmed andstudy exit occurs.
7. Subjects will refrain from donating blood or plasma during the study period.
8. Subjects will be advised to refrain from excessive alcoholic consumption during thestudy period. (No more than 15 drinks per week and no alcohol consumption within 24hours of a study visit.)
9. No known or suspected current alcohol dependence syndrome, chronic marijuana use, orany illicit drug use that may affect metabolism/transformation of steroid hormones andstudy treatment compliance.
10. In the opinion of the investigator, subject is able to comply with the protocol,understand and sign an informed consent and HIPAA form.
11. Subjects will be advised to refrain from major changes in their level of exerciseduring the study period.

Exclusion Criteria: Men who meet any of the following criteria are NOT eligible for enrollment in the trial:

1. Men participating in another clinical trial involving an investigational drug withinthe 30 days prior to the first screening visit.
2. Men not living in the catchment area of the clinic or within a reasonable distancefrom the study site.
3. Clinically significant abnormal physical and laboratory findings at screening.
4. Elevated PSA (levels ≥ 2.5 ng/mL) at screening, according to local laboratory normalvalues.
5. Abnormal serum chemistry values at screening, according to local laboratory referenceranges that indicate liver or kidney dysfunction or that may be considered clinicallysignificant. In addition, the following upper limits will be observed: fastingbilirubin less than 2 mg/dL, cholesterol less than 221 mg/dL, and fastingtriglycerides less than 201 mg/dL.
6. Abnormal semen analyses or abnormal semen concentration as defined by the WHO semenmanual.
7. Use of androgens within 3 months before first screening visit except for long actingtestosterone injections (e.g. Testosterone undecanoate) which will require a wash outperiod of 6 months prior to screening.
8. Ongoing use of body building substances including nutritional supplements.
9. Systolic BP > 130 mm Hg and Diastolic blood pressure BP > 80 and mm Hg; Blood pressure (BP) will be taken 3 times at 5 - minute intervals and the mean of all measurements beused to determine eligibility).
10. Clinically significant abnormal EKG or a QTc interval of > 450 msec.
11. PHQ-9 score of 15 or above.
12. History of hypertension, including hypertension controlled with treatment.
13. Known history of primary testicular disease or disorders of the hypothalamic-pituitaryaxis.
14. Benign or malignant liver tumors; active liver disease.
15. History of breast carcinoma.
16. Known history of androgen deficiency due to hypothalamic-pituitary or testiculardisease.
17. Known history of cardiovascular, renal, hepatic or prostatic disease or significantpsychiatric illness.
18. Positive serology for active Hepatitis (not immunization-related serology) or HIV atscreening visit.
19. A serious systemic disease such as diabetes mellitus or obesity (body weight greaterthan BMI >33 kg/m2 as above).
20. History of known, untreated sleep apnea.
21. Partner is known to be pregnant. 23. Men desiring fertility within the first sevenmonths of study participation.
22. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testingpositive for androgens that may occur from their study participation coupled with theunknown efficacy (i.e. duration of positive testing) from a single injection.
23. Use of sex steroids or medications which might interfere with steroid metabolism (i.e.ketoconazole, finasteride, oral corticosteroids, dutasteride and statins).
24. Use of medications that will interfere or interact with DMAU.