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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: BCD-147

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 196143
    • Medical Center "Eco-Safety"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Tolerated Dose (MTD)	28 days
The percentage of volunteers with treatment-emerged adverse events of any grade per NCI CTCAE 5.0	28 days
The percentage of volunteers with treatment-emerged adverse events of grade 3 and higher per NCI CTCAE 5.0	28 days
The percentage of volunteers with both binding and neutralizing antibodies	28 days

Collaborators and Investigators

• Sponsor: Biocad
• Investigators: Study Director: Roman A Ivanov, Vice President R&D, JSC BIOCAD

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BCD-147-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No