Clinical trials: sponsored by 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
Paroxysmal Nocturnal Hemoglobinuria
Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria
This clinical study is a randomized, open-label, international, multi-center, comparative study of efficacy and safety of BCD-148 and Soliris® in PNH patients.
- Trial name
- NCT04060264
- Testing
- BCD-148, Soliris
- Where
- Russia
- Volunteers
- 28 people
- Sponsor
- Biocad
Non Small Cell Lung Cancer Stage IIIB, Non-Small Cell Carcinoma of Lung, TNM Stage 4
Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)
International multi-center open-label randomized clinical trial of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as second-line therapy of patients with advanced…
- Trial name
- DOMINUS (NCT03288870)
- Testing
- BCD-100, Docetaxel
- Where
- 8 sites in Belarus, Russia
- Volunteers
- 218 people
- Sponsor
- Biocad
Melanoma
International Trial of the Efficacy and Safety of BCD-100 in Patients With Melanoma
An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients with Unresectable/Metastatic Melanoma.
- Trial name
- MIRACULUM (NCT03269565)
- Testing
- BCD-100
- Where
- 9 sites in Russia
- Volunteers
- 126 people
- Sponsor
- Biocad
Cervical Cancer
Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA)
This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without…
- Trial name
- FERMATA (NCT03912415)
- Testing
- BCD-100, Bevacizumab, Paclitaxel
- Where
- 26 sites in China, Georgia and 2 more
- Volunteers
- 316 people
- Sponsor
- Biocad
Healthy
First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects
This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers
- Trial name
- NCT03912441
- Testing
- BCD-147
- Where
- Russia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Biocad
Non-Squamous Non-Small Cell Neoplasm of Lung
Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy as First Line Treatment in Patients With Advanced Non-Squamous NSCLC
This is a randomized, multicenter, double-blind placebo-controlled phase 3 study of efficacy and safety of BCD-100 in combination with pemetrexed+cisplatin/carboplatin compared to placebo in combination with…
- Trial name
- DOMAJOR (NCT03912389)
- Testing
- BCD-100, Pemetrexed, Cisplatin (or carboplatin)
- Where
- 37 sites in Czechia, Georgia and 4 more
- Volunteers
- 292 people
- 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
Liver Cirrhosis, Biliary
Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis
BCD-085 is an innovative drug, anti-interleukin-17 monoclonal antibody. The aim of the study is to evaluate the efficacy and safety of BCD-085 in patients with primary biliary cholangitis (PBC).
- Trial name
- NCT03476993
- Testing
- BCD-085
- Where
- 3 sites in Russia
- Volunteers
- 9 people
- 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
Rheumatoid Arthritis
Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid…
- Trial name
- NCT02762838
- Testing
- BCD-055, Remicade®, Methotrexate
- Where
- 39 sites in Belarus, India and 1 more
- Volunteers
- 426 people
- Sponsor
- Biocad
Melanoma
Phase I Study of BCD-145 (Anti-CTLA-4) in Patients With Unresectable/Metastatic Melanoma
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) Monotherapy in Patients with Unresectable/Metastatic Melanoma.
- Trial name
- NCT03472027
- Testing
- BCD-145
- Where
- 4 sites in Russia
- Volunteers
- 15 people
- Sponsor
- Biocad
Cervical Cancer, Cervical Cancer Metastatic
Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer (CAESURA)
This is a multicenter, open-label, single-arm study of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) in combination with platinum-based chemotherapy and bevacizumab as first-line treatment in patients with…
- Conditions
- Cervical Cancer, Cervical Cancer Metastatic, Cervical Cancer Recurrent
- Trial name
- NCT03912402
- Testing
- BCD-100, Bevacizumab, Paclitaxel
- Where
- 24 sites in Russia
- Volunteers
- 49 people
- 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
Melanoma, Lung Cancer
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of BCD-100 in Patients With Advanced Solid Tumors
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors
- Conditions
- Melanoma, Lung Cancer, Renal Cell Carcinoma
- Trial name
- NCT03050047
- Testing
- BCD-100
- Where
- 4 sites in Russia
- Volunteers
- 15 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
Hepatitis, Hepatitis C
An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.
- Trial name
- NCT01889433
- Testing
- Algeron, Pegasys
- Where
- 19 sites in Belarus, India and 2 more
- Volunteers
- 170 people
- Sponsor
- Biocad