An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects

A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects.

This is a Phase 1, single-center, prospective, randomized, double-blind study of multiple ascending doses (MAD) of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 3 cohorts of 8 subjects each will be randomized to receive multiple IV doses of CD101 Injection or placebo infusions. Dose levels of CD101 Injection to be assessed will follow an ascending multiple-dose regimen.

Inclusion Criteria:

• Men must be surgically sterilized or using contraception,
• No significant findings on physical exam, ECG, clinical laboratory tests,
• Body mass index (BMI) between 18.5 and 32.0 kg/m2, inclusive
• Must provide written informed consent

Exclusion Criteria:

• Females of child bearing potential
• Signs and or symptoms of acute illness or chronic disease
• 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