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Filter by:: This is a Phase I, study to evaluate the safety and pharmacokinetics of oral OPRX-106 in healthy volunteers. Up to 18 healthy male subjects (age 18 years and older) will be randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving OPRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects will receive once daily oral administrations of OPRX-106 for 5 consecutive days. Subjects will remain at the clinical center for 24 hours after the first administration (Day 1) of OPRX-106 including PK sampling and then return to the site daily for additional administrations and study procedures.
Researchers want to find out how Minocycline Extended-Release Tablets affect sperm-production in healthy males. The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of minocycline, compared with a placebo or inactive pill. Approximately 170 healthy adult males will be assigned by chance (like flipping a coin) to 2 treatment groups with approximately 85 subjects per group. You will be treated with either Minocycline Extended-Release Tablets or placebo once daily. Screening will occur within 14 days prior to the first dose of study drug. Required study activities include: - Written informed consent - Weight - Two semen collections within 48-72 hours of one another at the screening visit and Days 84,112, 140, and 168 - Blood draws at the screening visit and Days 84, 112, 140, and 168 - Genital examination (excluding prostate) at screening and at the Day 84 and Day 112 visits - Medical history You will continue in the treatment phase of the study for 12 weeks. You will return to the clinic 4 weeks and 8 weeks after completion of the treatment phase of the study, with the final study visit approximately 12 weeks after the last dose. Participation will be for 24-weeks. Up to 10 investigational sites will enroll subjects into the study.