A Phase 1 Study of CDX-0159 | NCT04146129

Studies
A Phase 1 Study of CDX-0159

NCT04146129

Sponsor

Celldex Therapeutics

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

CDX-0159
Normal saline

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

Jul 2020

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

Oct 29, 2019Actual

Primary Completion Date

Apr 6, 2020Actual

Completion Date

Jun 26, 2020Actual

First Submitted Date

Oct 29, 2019

First Submission Date that Met QC Criteria

Oct 29, 2019

First Posted Date

Oct 31, 2019Actual

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

Jul 2, 2020

Last Update Posted Date

Jul 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

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

This is a study to determine the safety of CDX-0159 in healthy subjects.

Detailed Description

CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells.

This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.

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
CDX-0159	Experimental	Eligible subjects will receive a single dose of CDX-0159	Drug: CDX-0159
Normal saline	Placebo Comparator	Subjects assigned to receive placebo will receive a single dose of normal saline	Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CDX-0159	Drug	Single dose of one of four dosages of CDX-0159	CDX-0159

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety as assessed by CTCAE v5.0	Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by CTCAE v5.0.	Day 1 to Day 43.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

An informed consent signed and dated by the subject.
Healthy volunteer aged 18-55.
In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 30 kg/m2
No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives
Both males and females of child bearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
Not a current smoker (or regular user of any nicotine containing product).
Willing to follow all study rules

Key Exclusion Criteria:

Women who are pregnant or nursing
History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication
Autoimmune disorders requiring more than topical medication
History of asthma requiring the use of inhaled medication within the past 5 years.
Vaccination with live vaccines within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
Positive urine test for alcohol and drugs of abuse.

Other Protocol defined inclusion and exclusion criteria could apply.

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

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations