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