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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02551549

Enrollment

Registered

2015-09-16

Start date

2015-09-30

Completion date

2016-01-31

Last updated

2017-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Subjects

Brief summary

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

Detailed description

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.

Interventions

DRUGCD101 IV

antifungal

DRUGPlacebo

Normal saline

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026