MedDataX Logo

Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®

NCT ID: NCT02762799

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-18

Study Completion Date

2016-11-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leucocytosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

neutrophil count filgrastim granulocyte colony-stimulating factor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Leucostim® --> Neupogen®, subcutaneous injections

Healthy volunteers in this group will receive single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.

Group Type EXPERIMENTAL

Leucostim®

Intervention Type BIOLOGICAL

Leucostim® is filgrastim biosimilar.

Neupogen®

Intervention Type BIOLOGICAL

Neupogen® --> Leucostim®, subcutaneous injections

Healthy volunteers in this group will receive single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.

Group Type EXPERIMENTAL

Leucostim®

Intervention Type BIOLOGICAL

Leucostim® is filgrastim biosimilar.

Neupogen®

Intervention Type BIOLOGICAL

Leucostim® --> Neupogen®, intravenous injections

Healthy volunteers in this group will receive single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29.

Group Type EXPERIMENTAL

Leucostim®

Intervention Type BIOLOGICAL

Leucostim® is filgrastim biosimilar.

Neupogen®

Intervention Type BIOLOGICAL

Neupogen® --> Leucostim®, intravenous injections

Healthy volunteers in this group will receive single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29.

Group Type EXPERIMENTAL

Leucostim®

Intervention Type BIOLOGICAL

Leucostim® is filgrastim biosimilar.

Neupogen®

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Leucostim®

Leucostim® is filgrastim biosimilar.

Intervention Type BIOLOGICAL

Neupogen®

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

filgrastim filgrastim

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Written informed consent.
* Male gender.
* Age between 18 and 45 years.
* Normal body mass index.
* Verified diagnosis "healthy", established according to the anamnesis, physical examination and laboratory findings.
* Absence of alcohol or drug abuse.

Exclusion Criteria

* History of use of filgrastim.
* Allergy to any components of study drugs.
* Acute hemorrhage, donation of blood / plasma or blood transfusions during last 2 months prior to enrollment in the study, history of chronic bleeding.
* Surgical interventions during last 30 days prior to screening or planed surgical intervention during the study.
* Any diseases that could interfere with pharmacokinetics of filgrastim, including chronic liver, liver or blood diseases, diseases of cardiovascular, lung and neuroendocrine systems.
* Fever with body temperature higher than 40°С.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biocad

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roman Ivanov, PhD

Role: STUDY_CHAIR

JCS BIOCAD

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BCD-002-1

Identifier Type: -

Identifier Source: org_study_id