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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02516904

Enrollment

Registered

2015-08-06

Start date

2015-07-31

Completion date

2015-10-31

Last updated

2024-05-22

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 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.

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

* 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

Design outcomes

Primary

Measure	Time frame
Number of subjects with clinically significant adverse events (AEs)	Up to 3 weeks

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

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