A Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intr… (NCT02439359) | Clinical Trial Compass
CompletedPhase 1
A Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Subjects
United States20 participantsStarted 2015-05
Plain-language summary
A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Subjects.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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
✓. Be a healthy female of any race or ethnicity of non-childbearing potential between 18 and 55 years of age, inclusive. OR
✓. Be a healthy non-pregnant, non-lactating female of any race or ethnicity of childbearing potential between 18 and 55 years of age,
✓. Contraception in use for at least 60 days prior to the Screening visit,
✓. Have a body mass index (BMI) between 18.5 and 32 kg/m2, inclusive
✓. Have no significant diseases in the opinion of the Investigator in the medical history or clinically significant findings on physical examination or clinical laboratory evaluations.
Exclusion criteria
✕. 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) systems.
✕. The presence of clinically significant laboratory values that are out of the normal range.
✕. 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.
✕. Has smoked within 28 days prior to receiving study drug or has a positive urine test for cotinine.