Clinical trials: sponsored by Biocad
Non-small Cell Lung Cancer
A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung Cancer
BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN: bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in inoperable or advanced non-squamous NSCLC patients…
- Trial name
- NCT01763645
- Testing
- Bevacizumab, Paclitaxel, Carboplatin
- Where
- 44 sites in Belarus, India and 2 more
- Volunteers
- 353 people
- Sponsor
- Biocad
Multiple Sclerosis
Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis
Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years.
- Trial name
- NCT02727907
- Testing
- BCD-033 (interferon beta 1a), Rebif (interferon beta 1a)
- Where
- Russia
- Volunteers
- 163 people
- Sponsor
- Biocad
Moderate to Severe Plaque Psoriasis
An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis
BCD-085 is an innovative drug, a monoclonal antibody against interleukin-17. The toxicity, safety, and pharmacokinetics of BCD-085 were investigated in animals, in phase I clinical study in healthy volunteers, and in phase III…
- Trial name
- BCD-085-7 (NCT03390101)
- Testing
- BCD-085 Q2W, BCD-085 Q4W
- Where
- Russia
- Volunteers
- 213 people
- Sponsor
- Biocad
Healthy
Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and…
- Trial name
- NCT02395055
- Testing
- Adalimumab (BCD-057), Adalimumab (Humira)
- Where
- Russia
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Biocad
Psoriasis
International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous…
- Trial name
- NCT02762994
- Testing
- BCD-085
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Biocad
Anemia
Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis
BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease…
- Trial name
- NCT03519243
- Testing
- BCD-131, Mircera
- Where
- 3 sites in Belarus, Russia
- Volunteers
- 75 people
- Sponsor
- Biocad
Healthy
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against human IL-17 - BCD-085.
- Trial name
- NCT02380287
- Testing
- humanized monoclonal antibody against human IL-17
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy
First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against the…
- Trial name
- NCT03103438
- Testing
- BCD-089
- Where
- Russia
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy Subjects
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers
- Trial name
- NCT04027803
- Testing
- BCD-148, Soliris
- Where
- Russia
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Biocad
Chronic Kidney Disease, End Stage Renal Failure on Dialysis
Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients
The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.
- Conditions
- Chronic Kidney Disease, End Stage Renal Failure on Dialysis, Anemia
- Trial name
- NCT02506868
- Testing
- Darbepoetin alfa
- Where
- 30 sites in Russia
- Volunteers
- 196 people
- Sponsor
- Biocad
Healthy
The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers
BCD-066 is a darbepoetin alfa. Clinical study BCD-066-3 is a double-blind controlled, randomized, parallel-group study of the pharmacokinetics, pharmacodynamics, tolerability, and safety of multiple intravenous injections of…
- Trial name
- NCT03693950
- Testing
- BCD-066, Aranesp
- Where
- Russia
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Biocad
Reticulocyte Count
Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers
BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy Volunteers
- Trial name
- NCT02731469
- Testing
- BCD-131, Mircera®, Aranesp®
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Biocad
Leucocytosis
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
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®
- Trial name
- NCT02762799
- Testing
- Leucostim®, Neupogen®
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Biocad
Human Epithelial Receptor (HER)-2 Positive Breast Cancer
A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy.
- Trial name
- NCT01764022
- Testing
- Trastuzumab, Paclitaxel
- Where
- 36 sites in Belarus, India and 2 more
- Volunteers
- 225 people
- Sponsor
- Biocad
Hepatitis, Hepatitis C
An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and and PegIntron (Peginterferon Alfa-2b) in Combination With Ribavirin as Combined Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1…
- Conditions
- Hepatitis, Hepatitis C, Hepatitis C/ Human Immunodeficiency Virus Coinfection
- Trial name
- NCT02103439
- Testing
- Algeron, PegIntron
- Where
- 6 sites in Russia
- Volunteers
- 140 people
- Sponsor
- Biocad
Healthy
Open Label Study of Tolerability, Pharmacokinetics and Pharmacodynamics of BCD-054 (Pegylated Interferon Beta-1a), IM and SC, Compared to Rebif® and Avonex® in Healthy Volunteers
This is an international multicenter study of tolerability, pharmacokinetics and pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular and subcutaneous, compared to Rebif® (Merck Serono…
- Trial name
- NCT02359877
- Testing
- BCD-054, Rebif, Avonex
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Biocad
Chemotherapy-induced Neutropenia
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.
- Trial name
- NCT01569087
- Testing
- empegfilrastim, filgrastim
- Where
- 5 sites in Russia
- Volunteers
- 60 people
- Sponsor
- Biocad
Chemotherapy-induced Neutropenia
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
- Trial name
- NCT02104830
- Testing
- Empegfilrastim 6 mg, Filgrastim, Empegfilrastim 7.5 mg
- Where
- 13 sites in Russia
- Volunteers
- 135 people
- Sponsor
- Biocad
Deep Vein Thrombosis
A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries
The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.
- Trial name
- NCT02368314
- Testing
- Sodium Enoxaparine
- Where
- Russia
- Volunteers
- 124 people
- Sponsor
- Biocad
Healthy
Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers
This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen Europe B.V., Netherlands) in healthy…
- Trial name
- NCT02506881
- Testing
- Darbepoetin alfa
- Where
- Russia
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Biocad