Single Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of BDM-2 in Healthy Male Subjects.
Condition: Healthy
Intervention: BDM-2 in Bottle (50 mg - 3600 mg); oral suspension
Intervention description: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In Sessions I to VI, 6 single, orally administered ascending doses of BDM-2 or placebo will be investigated, alternately dosed in 2 cohorts of 8 healthy male subjects each (Cohorts A and B). For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo. In Sessions I to VI, doses are planned to be administered under fasted conditions.
Masking: Double (Participant, Investigator)
Masking description: double-blind, placebo-controlled
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; tolerability; pharmacokinetics

Summary:

      This is a first-in-human (FIH), double-blind, placebo-controlled, randomized trial in healthy
      adult male subjects, to evaluate the safety, tolerability and pharmacokinetics (PK) of single
      ascending oral doses of BDM-2. The effect of food on the PK of a single dose of BDM-2 will
      also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male aged between 18 and 55 years at screening, inclusive.

          2. Body Mass Index (BMI) 18.0-32.0 kg/m2 at screening, inclusive.

          3. Good physical and mental health as established by medical history, physical
             examination, respiratory rate, electrocardiogram (ECG) and vital signs (including body
             temperature) recording, and results of biochemistry, coagulation, hematology and
             urinalysis tests during screening as judged by the investigator.

          4. Non-smoker/non-user of nicotine containing products for at least 3 months prior to
             screening, to be confirmed by a urine cotinine dipstick test at screening and on Day
             -1 of the first session.

          5. Availability and willingness to complete the trial and follow the instructions of the
             investigator or trial-site personnel.

          6. Willing and able to adhere to the prohibitions and restrictions specified in the
             protocol

          7. Easy venous accessibility.

          8. Must have signed an Informed Consent Form (ICF) prior to screening, indicating that he
             understands the purpose of, and procedures required for the trial, and is willing to
             participate in the trial.

          9. Must agree to provide a blood sample for DNA research.

         10. Subject who is heterosexually active with a woman of childbearing potential must agree
             to use 2 effective methods of birth control (i.e., male condom with either female
             intrauterine device, diaphragm, cervical cap or hormone-based contraceptive), during
             the trial and for at least 90 days after receiving the last dose of trial medication.
             If the female sexual partner is postmenopausal for at least 2 years, or is surgically
             sterile (has had a total hysterectomy, bilateral oophorectomy, or bilateral tubal
             ligation/bilateral tubal clips without reversal operation), or otherwise is incapable
             of becoming pregnant, the birth control methods mentioned are not applicable, however,
             subjects should use a condom during the trial and for at least 90 days after receiving
             the last dose of trial medication to prevent unintended exposure via the ejaculate.

             Subjects who had vasectomy and have a female partner of childbearing potential must
             use a male condom during the trial and for at least 90 days after receiving the last
             dose of trial medication.

             Note: A male and female condom should not be used together due to risk of breakage or
             damage caused by latex friction.

             Note: Sexual abstinence is considered a highly effective method only if defined as
             refraining from heterosexual intercourse during the entire period of risk associated
             with the trial medication (during the trial and for at least 90 days after receiving
             the last dose of trial medication). The reliability of sexual abstinence needs to be
             evaluated in relation to the duration of the trial and the preferred and usual
             lifestyle of the subject.

             Note: Subjects will be instructed that if their partner becomes pregnant during the
             trial this should be reported to the investigator. The investigator should also be
             notified of pregnancy occurring during the trial but confirmed after completion of the
             trial. In the event that a subject's partner is subsequently found to be pregnant
             after the subject is included in the trial, then consent will be sought from the
             partner and, if granted, any pregnancy will be followed and the status of mother
             and/or child will be reported to the sponsor after delivery.

         11. Must agree not to donate sperm during the trial and for at least 90 days after
             receiving the last dose of trial medication.

        Exclusion Criteria:

          1. History of or current clinically significant medical illness including (but not
             limited to) gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic,
             endocrinologic, genitourinary, renal, hepatic, respiratory, inflammatory, neoplastic,
             or infectious disease, or any other illness that the investigator considers should
             exclude the subject or that could interfere with the interpretation of the trial
             results.

          2. Clinically significant abnormalities of hematology or biochemistry (out of range
             values should be considered as to their significance and the subject not included if
             the value is considered to be detrimental). This includes but is not limited to liver
             function tests.

          3. Subjects with Gilbert's syndrome.

          4. Clinically significant presence or history of allergy or intolerance (including
             lactose), or presence or history of clinically significant allergy requiring
             treatment, as judged by the investigator (hay fever is allowed unless it is active).

          5. Positive serology for hepatitis A virus (HAV) immunoglobulin M (IgM), hepatitis B
             virus surface antigen (HBsAg), anti-hepatitis C virus antibodies (anti-HCV-AB), or
             anti HIV antibodies 1+2 (anti-HIV-AB 1+2) at screening.

          6. History of alcohol or drug abuse within the last 2 years before screening or positive
             test result(s) for alcohol and/or drugs of abuse at screening or on Day -1 of first
             session.

          7. Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40%
             spirit or a 125 mL glass of wine).

          8. Surgery of gastro-intestinal tract that might interfere with absorption (subjects who
             have had cholecystectomy may be included). Subject has currently significant and
             active diarrhea, nausea, or constipation that in the investigator's opinion could
             influence drug absorption or bioavailability.

          9. Intake of any disallowed therapies before the first dose of trial medication (on Day 1
             of the first session).

         10. Donation of blood or blood products or substantial loss of blood (more than 500 mL)
             within 3 months before first dose of trial medication (on Day 1 of the first session)
             or the intention to donate blood or blood products during the trial

         11. Major surgery, fracture, or prolonged immobilization (more than 2 weeks) within 3
             months preceding screening, or surgery has been planned during the time the subject is
             expected to participate in the trial.

         12. Unable to swallow solid, oral dosage forms (multiple capsules) whole with the aid of
             water (subjects may not chew, divide, dissolve, or crush the trial medication).

         13. Plans to father a child while enrolled in the trial or within 90 days after receiving
             the last dose of trial medication.

         14. History of hypersensitivity or idiosyncrasy to any of the components of the
             investigational drug.

         15. Participation in a clinical trial within 3 months before first dose of trial
             medication (on Day 1 of the first session).

         16. Participation in a trial of an investigational product or an experimental medical
             device within 3 months or within a period less than 5 times the drug's half-life,
             whichever is longer, prior to the first dose (on Day 1 of the first session) or during
             this trial.

         17. Trial site employee or immediate family members of a trial site or sponsor employee.

         18. Have previously been enrolled in this trial.