A Single Ascending Dose Study of CD101 IV in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: CD101 IVDrug: Placebo
- Registration Number
- NCT02516904
- Lead Sponsor
- Cidara Therapeutics Inc.
- Brief Summary
A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CD101 IV CD101 IV single intravenous infusion ascending dose Placebo Placebo normal saline
- Primary Outcome Measures
Name Time Method Number of subjects with clinically significant adverse events (AEs) Up to 3 weeks
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Profile as measured by: maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC), clearance (CL), volume of distribution (Vz), elimination rate constant (^z), terminal half-life (t1/2) Up to 3 weeks
Trial Locations
- Locations (1)
Celerion Inc
🇺🇸Tempe, Arizona, United States