Pharmacokinetic and Pharmacodynamics of B12019 and Neulas... | NCT02629562

Studies
Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

NCT02629562

Sponsor

Cinfa Biotech

Status

Completed

Last Update Posted

Oct 13, 2017Actual

Enrollment

172Actual

Phase

Phase 1

Conditions

Clinical Pharmacology

Interventions

B12019 and Neulasta

Countries

Germany

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 2016

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

Nov 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Not provided

First Submitted Date

Dec 10, 2015

First Submission Date that Met QC Criteria

Dec 10, 2015

First Posted Date

Dec 14, 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

Oct 12, 2017

Last Update Posted Date

Oct 13, 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

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

172Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	first dosing: single dose of 6mg of B12019 administered subcutaneously, second dosing: single dose of 6mg of Neulasta administered subcutaneously	Biological: B12019 and Neulasta
Arm 2	Experimental	first dosing: single dose of 6mg of Neulasta administered subcutaneously, second dosing: single dose of 6mg of B12019 administered subcutaneously	Biological: B12019 and Neulasta

Interventions

Name	Type	Description	Arm Group Labels	Other Names
B12019 and Neulasta	Biological	GCSF, Growth Colony Stimulating Factor	Arm 1 Arm 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK parameter AUC0-last	Area under the plasma concentration-time curve	6 weeks
PK parameter Cmax	Maximum observed drug concentration	6 weeks
PD parameter ANC	AUEC0-last	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subjects
Age ≥18 and ≤55 years
BMI 22.0 - 28.0 kg/m2
Non-smokers for at least 6 months prior to study start
General good health, based on a comprehensive medical history and physical examination
Adequate organ function and normal laboratory values (unless the investigator considers an abnormality to be clinically not relevant)
Negative hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) tests at screening
Signed informed consent

Exclusion Criteria:

Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta®
Previous exposure to filgrastim or pegfilgrastim
History of drug or alcohol abuse
Blood donations in the past 3 months prior to study start, or bone marrow or stem cell donor in the past 12 months (first dose)
Medical history of haematological disease, including sickle cell disorders
Recent infection (within 1 week prior to first dose)
Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory or neurological diseases, that in the opinion of the investigator may interfere with the aim of the study
Participation in an interventional or Phase I study in the last 3 months or is current a follow-up visit schedule for any study, or has participation in more than three studies of experimental drug products in the past 12 months prior to screening
Subjects with ANC values outside the normal laboratory range at screening
Use of prescription or over-the-counter drugs including vitamins within 4 weeks of first dosing
Abnormalities in ECG
Signs of dermatitis or skin abnormalities affecting the administration area and surroundings
History of cancer

Accepts Healthy Volunteers

Yes

Sex

Male

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