The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels
Condition: Oxidative Stress
Intervention: Placebo low dose; N Acetyl cysteine, 600mg (low dose); Proimmune 200 (FT061452) 3000mg low dose; Placebo (high dose); N Acetyl cysteine, 1200mg (high dose); FT061452, 6000mg high dose
Intervention description: This is a prospective randomized controlled pilot study, which will include twenty-four (24) healthy individuals.The first 12 subjects (low dose) will be randomized into three sub groups. The first group will be given a single dose of placebo.; The sub-group of four subjects (low dose) will be given a single dose of 600 mg of N-Acetyl Cysteine (NAC).; The sub-group of four subjects (low dose) will be given a single dose of Proimmune 200 (FT061452) 3000mg low dose'; The second sub set of 12 subjects (high dose) will be randomized into three sub groups. The first group will be given a single dose of placebo.; N Acetyl cysteine (high dose) N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.; Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glutathione; Antioxidant; Free radical; Oxidative stress; N-Acetyl Cysteine; Glutathione precursor

Summary:

      Glutathione is a powerful protective substance found within every cell in the body. It has
      been shown that glutathione levels go down as a person gets older, which makes a person more
      likely to get heart disease, high blood sugar problems and different kind of cancers.
      N-Acetyl Cysteine is used as a dietary supplement. It has been reported to increase
      glutathione levels in the body. The diet supplement called ProImmune is also changed by the
      body into glutathione. Therefore, the purpose of this study is to find out the effect of
      ProImmune in healthy people. This study will also help to prove whether or not the ProImmune
      is able to improve the blood levels of glutathione in healthy people.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects will be healthy male or female, 30 to 65 years of age.

          2. Subjects must have a BMI between 20 and 35.

          3. Subjects must be able to provide informed consent after risks and benefits have been
             explained.

          4. Subjects must be non-smoking (defined as a subject who has not smoked for ≥ 6 months),
             and must agree to abstain from caffeine 72 hours prior to study day.

          5. Subjects are in generally good health, based on pre-study medical history, physical
             examination and routine laboratory tests.

          6. Subjects have, in the Investigator's opinion, no clinically significant disease and/or
             clinically significant abnormal laboratory values as determined by the Investigator
             based on medical history, physical examination, or laboratory evaluations conducted at
             the screening visit or on admission to the clinic.

        Exclusion Criteria:

          1. Subjects who have a history of drug or alcohol abuse within 6 months of study
             screening, as determined by the Investigator.

          2. Subjects who have participated in any investigational trial within 30 days or six
             half-lives of the test drug's biologic activity, whichever is longer, before the start
             of the study (time of first dose).

          3. Subjects who have clinically significant medical or psychiatric illnesses currently or
             within 30 days of start of study (time of first dose), as determined by 3. the
             Investigator.

          4. Subjects who have had symptoms of any significant acute illness within 30 days prior
             to the start of study (time of first dose),

          5. Subjects who have any condition that interferes with their ability to understand or
             comply with the requirements of the study.

          6. Females who are pregnant or nursing or have a high likelihood of becoming pregnant
             during the study.