NCT02516904

Brief Summary

A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 22, 2024

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

July 31, 2015

Last Update Submit

May 20, 2024

Conditions

Healthy

Keywords

Subjects

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with clinically significant adverse events (AEs)

    Up to 3 weeks

Secondary Outcomes (1)

  • 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

Study Arms (2)

CD101 IV

EXPERIMENTAL

single intravenous infusion ascending dose

Drug: CD101 IV

Placebo

PLACEBO COMPARATOR

normal saline

Drug: Placebo

Interventions

CD101 IVDRUG

antifungal

CD101 IV
PlaceboDRUG

normal saline

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion Inc

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

echinocandin CD101 IV

Study Officials

  • Danielle Armas, MD

    Celerion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 6, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 22, 2024

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)