A Single Ascending Dose Study of CD101 IV in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV
This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending single-dose regimen.
Inclusion Criteria: Males surgically sterilized or using contraception, No significant findings on physical, ECG, clinical laboratory tests, BMI between 18.5 - 32.0, Must provide informed consent Exclusion Criteria: Females of child bearing potential, Signs and or symptoms of an acute or chronic illness, Use of prescription medications within 28 days, Use of OTC, supplements, and herbals within 14 days, Current smoker Previous participation in a clinical study within 28 days