Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a 1 mg/kg Intravenous Dose in Healthy Adults

Inclusion Criteria: * Healthy adult male or female volunteers, 18-60 years of age, inclusive. * Weigh at least 52 kg for males and 45 kg for females and within the normal range according to accepted normal values of the Body Mass Index (BMI) chart 18.5-29.9 kg/m² inclusive. * Medically healthy with no clinically significant laboratory profiles, vital signs, or ECG's; as deemed by the PI. * For females of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using acceptable birth control methods. Female subjects who claim to be sexually inactive, but become sexually active during the course of the study must agree to use a barrier method (e.g. condom, diaphragm)with spermicide from the time of the start of sexual activity through at least 30 days following dosing. In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 30 days following dosing. * Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1: * Hysteroscopic tubal ligation (with a copy of the confirmation test) and be using a barrier method (condom or diaphragm) and spermicide throughout the study; * Bilateral tubal ligation and be using a barrier method (condom or diaphragm) and spermicide throughout the study; * Hysterectomy; * Bilateral oophorectomy …