Study of Pharmacokinetics, Pharmacodynamics, Safety of BC... | NCT02731469

NCT02731469

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BCD-131, 0.05 mcg/kg subcutaneously	Experimental	Healthy volunteers will receive BCD-131 in a dose 0.05 mcg/kg subcutaneously	Biological: BCD-131
BCD-131, 0.15 mcg/kg subcutaneously	Experimental	Healthy volunteers will receive BCD-131 in a dose 0.15 mcg/kg subcutaneously	Biological: BCD-131
BCD-131, 0.40 mcg/kg subcutaneously	Experimental	Healthy volunteers will receive BCD-131 in a dose 0.40 mcg/kg subcutaneously	Biological: BCD-131
BCD-131, 1.05 mcg/kg subcutaneously	Experimental	Healthy volunteers will receive BCD-131 in a dose 1.05 mcg/kg subcutaneously	Biological: BCD-131
BCD-131, 1.70 mcg/kg SC	Experimental	Healthy volunteers will receive BCD-131 in a dose 1.70 mcg/kg subcutaneously	Biological: BCD-131
BCD-131, 2.25 mcg/kg SC	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BCD-131	Biological		BCD-131, 0.05 mcg/kg subcutaneously BCD-131, 0.15 mcg/kg subcutaneously BCD-131, 0.40 mcg/kg subcutaneously BCD-131, 1.05 mcg/kg subcutaneously BCD-131, 1.70 mcg/kg SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC (0-1176 Hours)	Area under curve (AUC) "concentration - time" from 0 hours to 1176 hours and to infinity	0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 h post dose

Secondary Outcomes

Measure	Description	Time Frame
Cmax	Maximal concentration of drug in blood after single injection	0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
Tmax

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signing of the Informed Consent Form;
Male sex;
Age of 18 to 45 years, inclusive;
BMI within normal limits (18.5-24.9 kg/m2);
Healthy patients, which is proved by their medical history, physical examination and laboratory findings:
- No clinically significant abnormalities of circulatory, respiratory, nervous, hematopoietic, endocrine and digestive systems, liver and kidneys in the past medical history and at screening;
- No history of cardiovascular disorders or thyroid disorders;
- No history of hematologic disorders, including but not limited to any type of anemia, myelodysplastic syndrome, blood cancers, hemolytic syndrome, hemoglobinopathies, coagulopathies;
- CBC results within normal limits, including:
  - Hemoglobin within 132-173 g/L;
  - Hematocrit (based on CBC results) within 39-49%;
  - Platelet count within 150-400*109/L;
  - Absolute reticulocyte count within 30.4-93.5 * 109/L;
- Blood biochemistry and urinalysis results within normal limits;
- Serum ferritin within 20-250 µg/L;
- Serum endogenous erythropoietin within 4.3-29.0 MIU/mL;
- Hemodynamic parameters within normal limits: systolic blood pressure within 100-139 mmHg; diastolic blood pressure within 60-90 mmHg; heart rate within 50-90 bpm;
- No history of chronic infections (tuberculosis) or chronic inflammation;
- No hepatitis B or C, HIV, or syphilis;
- No acute infections within 4 weeks prior to inclusion in the study;
- No psychiatric disorders and other conditions (including depression) that can interfere with the volunteer's ability to follow the study protocol;
- Well-being (in the volunteer's opinion) within 30 days prior to inclusion in the study;
No history of or current (at baseline) alcohol or drug abuse;
Ability of the volunteer, in the investigator's opinion, to follow the study protocol procedures;
Willingness of volunteers and their sexual partners with preserved reproductive potential to use reliable contraception within 2 weeks before inclusion in the study and up to 7 weeks after the injection of the test product. This criterion is not applicable to subjects who underwent surgical sterilization. Reliable methods of contraception include one barrier method in combination with one of the following methods: spermicides, intrauterine device/oral contraceptives (for sexual partners).
Willingness of volunteers to avoid alcohol intake within 24 hours before and 8 days after each injection of the test drug;

Exclusion Criteria:

History of treatment with erythropoietins or any other ESAs;
Acute bleeding, blood/plasma donation or blood transfusion within 2 months before inclusion in the study;
History of chronic bleeding;
Standard laboratory and instrumental findings outside normal limits at screening;
History of allergies (anaphylactic shock or multiple drug allergy syndrome);
Known allergy or intolerance to any components of the investigational product;
Major surgery within 30 days prior to screening, or surgery being scheduled for any time during the study;
Impossibility to install a venous catheter for blood sampling (e.g. because of skin disorders at the sites of venipuncture);
Diseases or other conditions that can interfere with the pharmacokinetics of the investigational drug (e.g. chronic liver, kidney, blood, circulatory system, lung or neuroendocrine diseases, including diabetes mellitus and others);
History of fever of 40 °C or more;
History of elevated hepatic transaminases (above 2.5xULN);
Episodes of thrombosis and/or thromboembolia in past medical history (myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary embolism within 6 months prior to inclusion in the study) as well as an increased risk of deep vein thrombosis;
History of epileptic attacks or seizures;
History or current (at screening) depression, suicidal thoughts/ attempts;
Regular oral or parenteral use of any medications including over-the-counter drugs, vitamins and nutritional additives within 2 weeks before a scheduled injection of the test drug;
Use of drugs, including OTC products, that significantly affect the hemodynamics, hepatic function, etc. (barbiturates, omeprazole, cimetidine, etc.) within 30 days before a scheduled injection of the test drug;
Vaccination within 4 weeks before a scheduled injection of the test drug;
Smoking more than 10 cigarettes per day;
Consumption of more than 10 portions of alcohol per week (one portion equals to 0.5 L of beer, 200 mL of wine or 50 mL of ethanol) or a history of alcohol, drug or medication abuse;
Participation in other clinical studies within 1 month before screening or simultaneous participation in another clinical study;
Previous participation in this study.

Contacts/Locations Module

Name	Affiliation	Role
Roman Ivanov, PhD	JCS BIOCAD	Study Chair

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	BCD-131, 0.05 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131
FG001	BCD-131, 0.15 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131
FG002	BCD-131, 0.40 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131
FG003	BCD-131, 1.05 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131
FG004	BCD-131, 1.70 mcg/kg SC	Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131
FG005	BCD-131, 2.25 mcg/kg SC	Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131
FG006	BCD-131, 4.45 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131
FG007	Mircera®, 1.20 mcg/kg Subcutaneously	Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®
FG008	Aranesp®, 0.45 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®
FG009	BCD-131, Optimal Dose, Intravenously	Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131
FG010	BCD-131, Optimal Dose, Subcutaneously	Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0003 subjects FG0013 subjects FG0023 subjects FG0033 subjects FG0043 subjects FG0053 subjects FG0063 subjects FG0076 subjects FG0086 subjects FG0096 subjects FG0106 subjects
COMPLETED		FG0003 subjects FG0013 subjects FG0023 subjects FG0033 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	BCD-131, 0.05 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131
BG001	BCD-131, 0.15 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

AUC (0-1176 Hours)

Area under curve (AUC) "concentration - time" from 0 hours to 1176 hours and to infinity

Posted

Median

Inter-Quartile Range

pg*hr/ml

0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 h post dose

ID	Title	Description
OG000	BCD-131, 0.05 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131
OG001	BCD-131, 0.15 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131
OG002

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BCD-131, 0.05 mcg/kg Subcutaneously	Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
platelet count decreased	Blood and lymphatic system disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Yulia Linkova Medical Director	Biocad	+7 (495) 992 66 28	930	linkova@biocad.ru

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 21, 2015	Oct 7, 2018	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Sep 21, 2015	Oct 7, 2018	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

ID	Term
C508420	continuous erythropoietin receptor activator
D000068256	Darbepoetin alfa

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Masking Info

BCD-131, 2.25 mcg/kg SC

BCD-131, 4.45 mcg/kg subcutaneously

BCD-131, optimal dose, intravenously

BCD-131, optimal dose, subcutaneously

Time from 9 hours to time of maximal concentration of drug in blood after single injection

Inter-Quartile Range

EG0000 affected3 at risk

EG0011 affected3 at risk

EG0020 affected3 at risk

EG0030 affected3 at risk

EG0040 affected3 at risk

EG0050 affected3 at risk

EG0060 affected3 at risk

EG0070 affected6 at risk

EG0080 affected6 at risk

EG0090 affected6 at risk

EG0100 affected6 at risk

(2924.000 to 4954.000)

OG0043541.000(150.000 to 4110.000)

OG00512023.000(6863.000 to 12243.000)

OG00615433.000(13286.000 to 16404.000)

OG0072298.000(1849.000 to 6867.000)

OG008964.500(870.000 to 1229.000)

OG00987526.5(69859 to 93090)

OG01010588(3713 to 11692)

OG00472.000(48.000 to 168.000)

OG005120.000(96.000 to 168.000)

OG00696.000(72.000 to 96.000)

OG00748.000(48.000 to 72.000)

OG00836.000(8.000 to 36.000)

(326.648 to 506.316)

OG005191.477(145.071 to 495.813)

OG006181.310(168.649 to 186.681)

OG007114.855(105.888 to 256.031)

OG00879.473(44.619 to 104.605)

OG009116.125(70.7 to 120.38)

OG010182.392(123.71 to 197.76)

(0.001369 to 0.002122)

OG0050.003620(0.001398 to 0.004778)

OG0060.003823(0.003713 to 0.004110)

OG0070.006057(0.003734 to 0.006549)

OG0080.009019(0.006697 to 0.019655)

OG0090.005977(0.003424 to 0.006196)

OG0100.003828(0.001367 to 0.00415)

OG00492.812(91.843 to 1820.580)

OG00565.259(46.682 to 88.567)

OG00651.774(51.147 to 57.320)

OG007108.993(59.886 to 156.741)

OG008332.263(304.017 to 602.322)

OG00929.84(24.293 to 30.734)

OG010136.391(48.481 to 202.399)

(6006.000 to 13416.00)

OG00414481.60(10366.80 to 15530.40)

OG00525512.00(16476.00 to 30355.20)

OG00669120.00(46183.20 to 81511.20)

OG00710269.72(3121.200 to 16310.88)

OG00814223.60(8736.000 to 21257.28)

OG00921370.44(18081.6 to 22724.88)

OG01013129.2(4432.56 to 15072)

(2688.00 to 6924.00)

OG0041548.00(1320.00 to 10128.00)

OG0051392.00(660.00 to 23460.00)

OG0063516.00(2904.00 to 4248.00)

OG0073492.00(720.00 to 6156.00)

OG0083120.00(2112.00 to 4320.00)

OG0094008(2340 to 4044)

OG0104632(2448 to 4812)

OG00420.68(17.00 to 26.00)

OG005112.00(81.00 to 132.00)

OG006110.00(69.00 to 171.00)

OG00758.00(48.00 to 91.42)

OG00862.22(48.00 to 153.10)

OG00970.18(67 to 72.76)

OG01057.5(45.4 to 58)

OG0049.00(6.00 to 21.00)

OG0056.00(4.00 to 26.00)

OG00610.00(8.00 to 10.00)

OG00710.50(3.00 to 12.00)

OG0089.00(8.00 to 13.00)

OG00911.00(8.00 to 13.00)

OG01010.5(9.00 to 12.00)