An Ascending Multiple Dose Study of CD101 IV in Healthy S... | NCT02551549

Studies
An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects

NCT02551549

Sponsor

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status

Completed

Last Update Posted

Jun 26, 2017Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy

Interventions

CD101 IV
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Sep 14, 2015

First Submission Date that Met QC Criteria

Sep 15, 2015

First Posted Date

Sep 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2017

Last Update Posted Date

Jun 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CD101 IV	Experimental	multiple ascending dose intravenous infusion	Drug: CD101 IV
Placebo	Placebo Comparator	normal saline	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CD101 IV	Drug	antifungal	CD101 IV
Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Danielle Armas, MD	Celerion	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Celerion Inc		Tempe	Arizona	85283	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000623143	echinocandin CD101 IV

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided