Study of COR388 HCl in Healthy Subjects

A Phase 1 Single Ascending Dose Study of COR388 HCl

The study is a randomized, double-blind, placebo-controlled, dose escalation, first-in-human trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.

Major Inclusion Criteria:

1. Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from Day -1 through 28 days after the dose of study drug;
2. Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at screening visit and Day 1; agree to use double-barrier contraceptive measures or avoid intercourse from Day -10 through 28 days after the dose of study drug;
3. Body mass index (BMI) ≥19 to ≤32 kg/m2;
4. Good health as determined by the absence of clinically significant deviation from normal, by medical history, physical examination, laboratory reports, and 12-lead electrocardiogram (ECG) prior to enrollment;
5. Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for the duration of the study;
6. Able to understand and willing to comply with all study requirements, and follow the study medication regimen.

Major Exclusion Criteria:

1. History or current evidence of cardiac, hepatic, renal, pulmonary, endocrine, neurologic, gastrointestinal, hematologic, oncologic, infectious, or psychiatric disease as determined by screening history, physical examination, laboratory reports, or 12-lead ECG;
2. Need for any concomitant medication (with the exception of hormonal contraceptives as allowed for females of child-bearing potential);
3. Use of any prescription drug within 14 days prior to the first dose of the study (with the exception of hormonal contraceptives for females of childbearing potential);
4. Use of any non-prescription drug and/or herbal supplements within 7 days prior to the first dose of the study;
5. History of significant allergic reaction to any drug;
6. Participation in another investigational new drug research study within the 30 days prior to the first dose of the study;
7. History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator;
8. Positive urine screen for prohibited drugs or positive alcohol screen on Day -1.