A Single Ascending Dose Study of CD101 IV in Healthy Subj... | NCT02516904

Studies
A Single Ascending Dose Study of CD101 IV in Healthy Subjects

NCT02516904

Sponsor

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

Status

Completed

Last Update Posted

May 22, 2024Actual

Enrollment

32Actual

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

Jul 2015

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jul 31, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 6, 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

May 20, 2024

Last Update Posted Date

May 22, 2024Actual

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 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.

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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CD101 IV	Experimental	single intravenous infusion ascending dose	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
Number of subjects with clinically significant adverse events (AEs)		Up to 3 weeks

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

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