Phase 1
N=60
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
Leucocytosis
Bottom Line
View on ClinicalTrials.gov: NCT02762799 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: AUC (0-48 Hours) — 168603.588; 181152; 411826.811; 427355.99 picogram per ml / hour
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Leucostim® (Biological); Neupogen® (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Biocad
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC (0-48 Hours) |
168603.588; 181152; 411826.811; 427355.99 | — |
| PRIMARY Cmax After Subcutaneous Injection |
21605.163; 23389.559 | — |
| SECONDARY Cmax After Intravenous Injection |
79751.577; 90796.227 | — |
| SECONDARY Tmax After Injection |
4; 4; 0.5; 0.5 | — |
| SECONDARY Т½ |
4,386; 4,307; 2,746; 2,549 | — |
| SECONDARY Kel |
0.158; 0.161; 0.252; 0.272 | — |
| SECONDARY Clearance |
2048.087; 1981.707; 965.938; 830.442 | — |
| SECONDARY ANC-AUEC (0-336 Hours) |
1924.284; 1933.358; 1860.922; 1895.82 | — |
| SECONDARY ANC-Emax |
21.285; 20.803; 20.726; 21.602 | — |
| SECONDARY CD34-AUEC (0-336 Hours) |
1289; 1200.667; 1350.783; 1251.652 | — |
| SECONDARY CD34-Emax |
7.694; 7.056; 9; 7.522 | — |
| SECONDARY Overall Frequency of Serious Adverse Events (SAE) |
0; 0; 0; 0 | — |
| SECONDARY Overall Frequency of Adverse Events (AE) |
36; 35; 22; 22 | — |
| SECONDARY Frequency of Local Reactions |
0; 0; 0; 0 | — |
| SECONDARY Frequency of AE/SAE 3-4 Grade CTCAE 4.03 |
0; 1; 0; 0 | — |
| SECONDARY Frequency of Preliminary Withdrawal Due to AE/SAE |
0; 0; 0; 0 | — |
| SECONDARY Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim |
0; 0; 0; 0 | — |
Summary
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®
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02762799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.