A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability
of Single Intravenous Doses of CF-301 in Healthy Subjects.
1. Be a healthy male of any race or ethnicity, at least 18 years of age and no more than
55 years of age, inclusively, OR
2. Be a healthy female of any race or ethnicity of non-childbearing potential between 18
and 55 years of age, inclusive. OR
3. Be a healthy non-pregnant, non-lactating female of any race or ethnicity of
childbearing potential between 18 and 55 years of age,
4. Contraception in use for at least 60 days prior to the Screening visit,
5. Have a body mass index (BMI) between 18.5 and 32 kg/m2, inclusive
6. Have no significant diseases in the opinion of the Investigator in the medical
history or clinically significant findings on physical examination or clinical
1. Any disease or condition in the opinion of the Investigator that might compromise the
cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma),
endocrine (eg, diabetes), central nervous, or gastrointestinal (including an ulcer)
2. The presence of clinically significant laboratory values that are out of the normal
− Subjects with an aspartate aminotransferase (AST), alanine aminotransferase (ALT),
gamma-glutamyltransferase (GGT), alkaline phosphatase, bilirubin, blood urea nitrogen
(BUN), creatinine, prothrombin time (PT), or activated partial thromboplastin time
(aPTT) > 5% above the upper limit of normal, or hemoglobin or hematocrit level < 5%
below the lower limit of normal may not be enrolled.
3. A history of alcoholism or drug addiction, or illicit drug use within the past 2
years, or positive results from a urine screen for substances of abuse.
4. Has smoked within 28 days prior to receiving study drug or has a positive urine test
5. A history of serious mental illness.
6. A history of difficulty donating blood or inadequate venous access.
7. The donation of blood or plasma within 28 days prior to receiving study drug.
8. A positive hepatitis screen that tests for both hepatitis B surface antigen (HBsAg)
and antibody to hepatitis C virus (HCVAb).
9. A positive test result for human immunodeficiency virus (HIV) antibody by enzyme
immunoassay, which is confirmed by Western blot.
10. Use of an investigational drug or product, or participation in a drug study within a
period of 28 days prior to receiving study drug (for investigational drugs with an
elimination half-life greater than 10 days, this will be extended to 60 days).
11. Use of any prescription or over-the-counter (OTC) drug therapy, including herbal,
homeopathic, vitamins, minerals and nutritional supplements, within 2 weeks prior to
receiving the study drug contraceptives in women of childbearing potential is allowed
during the study.
− If a subject taking prescription drug therapy for chronic diseases, but that
prescription is stopped in order to qualify for the study, the subject should not be
enrolled in the study.
12. Use of any drug therapy (ie, prescription drugs, over-the counter products, herbal
and vitamin products) known to induce or inhibit cytochrome P450 hepatic enzymes
responsible for drug metabolism within 28 days prior to receiving study drug or
during the study.