Study of CXA-10 in Healthy Volunteers

Inclusion criteria

• ✓. Male subjects and female subjects of non-child bearing potential between the ages of 18 and 50 years (inclusive)
• ✓. Females must not be of child bearing potential (defined as bilateral oophorectomy, hysterectomy, or post-menopausal \[amenorrhea for minimum of 1 year and post-menopausal status confirmed by follicle stimulating hormone (FSH) testing\]). Female subjects unable to bear children (e.g. tubal ligation, hysterectomy, or post-menopausal) must have this documented in the case report form (CRF).
• ✓. Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 60 kg and 100 kg (inclusive)-Part A and B only
• ✓. BMI between 30 and 50 kg/m2 for subjects in Part C only
• ✓. In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis. Subjects in Part C only may be allowed to have blood pressure readings up to160/100.
• ✓. Subjects must have resting heart rates (HR) ≥50 beats per minute at baseline
• ✓. QTcF interval (Fredericia's correction factor) of the baseline ECG must be ≤430 msec for males and ≤450 msec for females at screening and predose. Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study. Subjects with a history of congenital long QT syndrome in the subject or in the subject's family will be excluded from the study (see Section 6.4.3.
• ✓. Adequate bilateral venous access to allow for repeated dose infusions and blood sampling

Exclusion criteria