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First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03912441
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Biocad

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Biological: BCD-147 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Non-Comparator Multicohort Trial of Pharmacokinetics, Safety And Immunogenicity of BCD-147 (JSC "BIOCAD", Russia) After Single Administration of Escalating Doses in Healthy Volunteers
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: BCD-147 Monotherapy Dose Level 1 Biological: BCD-147
Bispecific anti-HER2 monoclonal antibody

Experimental: BCD-147 Monotherapy Dose Level 2 Biological: BCD-147
Bispecific anti-HER2 monoclonal antibody

Experimental: BCD-147 Monotherapy Dose Level 3 Biological: BCD-147
Bispecific anti-HER2 monoclonal antibody

Experimental: BCD-147 Monotherapy Dose Level 4 Biological: BCD-147
Bispecific anti-HER2 monoclonal antibody




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ]
  2. The percentage of volunteers with treatment-emerged adverse events of any grade per NCI CTCAE 5.0 [ Time Frame: 28 days ]
  3. The percentage of volunteers with treatment-emerged adverse events of grade 3 and higher per NCI CTCAE 5.0 [ Time Frame: 28 days ]
  4. The percentage of volunteers with both binding and neutralizing antibodies [ Time Frame: 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form and the subject's ability to follow the Protocol requirements;
  2. Male gender 18-45 years of age inclusively at the signing of the informed consent;
  3. Body mass index (BMI) in the normal range (18.0 - 30.0 kg / sq.m.);
  4. Left ventricular ejection fraction is at least 55% measured by echocardiography;
  5. Volunteer's ability to follow Protocol's procedures;
  6. Verified diagnosis: "Healthy" according to standard clinical, laboratory, and instrumental examination methods;
  7. Hemodynamic parameters within the normal range: systolic blood pressure (BP) in the range of 90-130 mm Hg., diastolic blood pressure in the range of 60-90 mm Hg., heart rate - 60-90 beats / min;
  8. Consent of volunteers and their sexual partners with childbearing potential to use adequate contraception throughout the entire trial period. This includes the use of the 1st barrier method in combination with one of the following: spermicides, intrauterine device / oral contraceptives;
  9. Volunteer's ability not to drink alcohol within 24 hours prior to the administration of the drug and throughout the entire trial period.

Exclusion Criteria:

  1. Participation in any other clinical trial within 30 days before the signing of the informed consent for this clinical trial;
  2. Any condition that prevents a patient from following the Protocol procedures (dementia, neurological or mental disorders, drug/alcohol abuse, etc.);
  3. The inability of venous puncture for the collection of blood samples (e.g., due to skin diseases);
  4. Any surgical procedures that have been transferred within less than 28 days before the signing of the informed consent or planned within 28 days after completion of study participation;
  5. Presence of any disorders that, according to the researcher, may affect the pharmacokinetics and safety of the investigational drug;
  6. HBV/HCV/HIV infection, active syphilis;
  7. Acute infection or the acute phase of chronic infection within 28 days prior the first dose of the investigational product; Active HBV/HCV/HIV infection, active syphilis;
  8. Values of standard laboratory and instrumental indicators that go beyond the limits of laboratory standards adopted in the central laboratory;
  9. Use of medicines that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 28 days before the signing of informed consent and / or the need to take any medications throughout the entire study (except for the study drug);
  10. Regular use and parenteral administration of any drugs, including non-prescription drugs, vitamins and dietary supplements, less than 14 calendar days before the signing of informed consent;
  11. Known severe allergy (anaphylaxis or multidrug intolerance);
  12. Hypersensitivity to any of the components of BCD-147;
  13. Smoking of more than 10 cigarettes per day;
  14. Use of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml of wine or 50 ml of spirits) or anamnestic information about alcoholism, drug addiction or drug abuse, or positive tests for alcohol and / or psychotropic / narcotic substances during the screening visit;
  15. Donation of 450 ml or more of blood or plasma within 60 calendar days prior to the signing of informed consent;
  16. Cardiovascular disorders, including hypertension or hypotension;
  17. Edema of the lower limbs within 14 days before the signing of the informed consent;
  18. A history of clinically significant systemic diseases;
  19. Use of intravenous antibiotics within 7 days before the signing of informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912441


Contacts
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Contact: Mariia S Shustova, MD +7-(812)-380-49-33 biocad@biocad.ru
Contact: Ivan K Alvovskii +7-(812)-380-49-33 biocad@biocad.ru

Locations
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Russian Federation
Medical Center "Eco-Safety" Recruiting
Saint Petersburg, Russian Federation, 196143
Contact: Konstantin A Zakharov, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Sponsors and Collaborators
Biocad
Investigators
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Study Director: Roman A Ivanov Vice President R&D, JSC BIOCAD

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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT03912441    
Other Study ID Numbers: BCD-147-1
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antibodies
Immunologic Factors
Physiological Effects of Drugs