An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

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

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: CD101 IV
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD101 IV<br>multiple ascending dose intravenous infusion | Drug: CD101 IV<br>* antifungal<br>|
| Placebo Comparator: Placebo<br>normal saline | Drug: Placebo<br>* Normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by the number of subjects with clinically significant adverse events | Number of subjects with clinically significant adverse events (AEs) | Up to 2 weeks following last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) |  | Up to 2 weeks following last dose of study drug | 
| Time to reach peak plasma concentration (Tmax) |  | Up to 2 weeks following last dose of study drug | 
| Area under the concentration time curve (AUC) |  | Up to 2 weeks following last dose of study drug | 
| The volume of plasma cleared of the drug per unit time (CL) |  | Up to 2 weeks following last dose of study drug | 
| Apparent volume in which the drug is distributed (Vz) |  | Up to 2 weeks following last dose of study drug | 
| The rate at which a drug is removed from the body (^z), |  | Up to 2 weeks following last dose of study drug | 
| Terminal half-life (t1/2) |  | Up to 2 weeks following last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjects