NCT02551549

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 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

September 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

September 14, 2015

Last Update Submit

June 22, 2017

Conditions

Healthy

Keywords

Subjects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

CD101 IV

EXPERIMENTAL

multiple ascending dose intravenous infusion

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:

  • 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

You may not qualify if:

  • 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

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

September 14, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

June 26, 2017

Record last verified: 2017-06

Locations

US(1)