Study Evaluating ECG Effects, Safety, Tolerability and Pharmacokinetics of Single Doses of Modufolin (Arfolitixorin) in Healthy Volunteers Tetrahydrofolate in Healthy Male Volunteers
Condition: Phase I Study in Healthy Volunteers to Evaluate ECG Effect
Intervention: Modufolin (arfolitixorin)
Intervention description: Thirty-three eligible and consenting subjects will be included in 3 cohorts, 11 subjects in each cohort, Within each cohort, subjects will be randomized to receive either placebo (3 subjects) or Modufolin® for injection, 100mg (8 subjects)
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: An adaptive, randomized, double-blind, single-center, placebo-controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: IMP (Modufolin® for Injection, 100 mg) and Placebo are not identical in appearance and all efforts will be made at the clinic in order to maintain the blind. Both the IMP and the placebo will be masked in such a way that study subjects and study staff will remain blinded during the study. An un-blinded study nurse will prepare the IMP/placebo for injection and will administer the IMP/placebo to the study subject. The un-blinded study nurse performing the dose administration will not be involved in any study-specific assessments or evaluations.
Enrollment: 33.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluating ECG effects, safety, tolerability and
      pharmacokinetics of single ascending dose of Modufolin® in healthy male volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide a written informed consent for participation in the study.

          2. Healthy male subject aged 18-60 years inclusive.

          3. Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 and weight at least 50 kg and no more than
             100 kg at screening and body surface area ≤ 2 m2

          4. Clinically normal medical history, physical findings, vital signs, ECG and laboratory
             values at the time of screening, as judged by the Investigator.

          5. Willing to use condom and highly effective contraceptive methods with a failure rate
             of < 1% to prevent pregnancy1 and drug exposure to a partner and refrain from donating
             sperm from the date of dosing until 3 months after dosing of the IMP/placebo.

        Exclusion Criteria:

          -  1. History of any clinically significant disease or disorder which, in the opinion of
             the Investigator, may either put the subject at risk because of participation in the
             study, or influence the results or subject´s ability to participate in the study.

             2. Any clinically significant illness, medical/surgical procedure or trauma within
             four weeks of the first administration of IMP/placebo. 3. Any planned major surgery
             within the duration of the study. 4. Any positive result on screening for serum
             hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus
             (HIV). 5. After 10 minutes (min) supine rest at the time of screening, any vital signs
             values outside the following ranges:

               -  Systolic BP > 150 mm Hg

               -  Diastolic BP > 90 mm Hg

               -  Pulse < 40 or > 85 beats per min 6. Prolonged QTcF (>450 ms), cardiac arrhythmias
                  or any clinically significant abnormalities in the resting ECG at the time of
                  screening, as judged by the Investigator.

                  7. History of severe allergy/hypersensitivity or on-going
                  allergy/hypersensitivity, as judged by the Investigator, or history of
                  hypersensitivity to drugs with a similar chemical structure or class to
                  Modufolin® (i.e., folate derivatives). 8. Regular use of any prescribed or
                  non-prescribed medication including antacids, analgesics, herbal remedies,
                  vitamins and minerals within two weeks prior to the administration of
                  IMP/placebo, except occasional intake of paracetamol (maximum 2000 mg/day; and
                  not exceeding 3 000 mg/week), at the discretion of the Investigator and nasal
                  decongestants without cortisone or antihistamine for a maximum of 10 days, at the
                  discretion of the Investigator. 9. Regular use of any prescribed or
                  non-prescribed medication which could influence folate and vitamin B12 status
                  within 30 days prior to the administration of IMP/placebo.

                  10. Administration of another new chemical entity (defined as a compound which
                  has not been approved for marketing) or has participated in any other clinical
                  study that included drug treatment with less than three months between
                  administration of last dose and first dose of IMP/placebo in this study. Subjects
                  consented and screened but not dosed in previous phase I studies are not
                  excluded. 11. Current smokers or users of nicotine products. Irregular use of
                  nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times per
                  week is allowed before screening visit. 12. Positive screen for drugs of abuse or
                  alcohol at screening or on admission to the unit prior to administration of the
                  IMP/placebo. 13. Current or history of alcohol abuse and/or use of anabolic
                  steroids or drugs of abuse.

                  14. Intake of xanthine and/or taurine containing energy drinks within two days
                  prior to screening.

                  15. Plasma donation within one month of screening or blood donation (or
                  corresponding blood loss) during the three months prior to dosing. 16.
                  Investigator considers the subject unlikely to comply with study procedures,
                  restrictions and requirements.