Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
An Open-Label, Non-Comparative Study of the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses of BCD-261 After Single Subcutaneous Injection in Healthy Subjects
1 other identifier
interventional
48
1 country
1
Brief Summary
The goal of this clinical trial is to investigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 after single subcutaneous injection at ascending doses and proposed therapeutic doses to healthy male subjects aged from 18 to 45 years old. The study consists of the first stage (dose escalation) and the second stage (dose expansion).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2024
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2024
CompletedFirst Submitted
Initial submission to the registry
November 28, 2024
CompletedFirst Posted
Study publicly available on registry
December 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 16, 2024
December 1, 2024
10 months
November 28, 2024
December 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Proportion of subjects with adverse reactions
127 days
Proportion of subjects with serious adverse reactions
127 days
Proportion of subjects with CTCAE 5.0 grade 3 or higher adverse reactions
127 days
Proportion of subjects who prematurely withdrew from the study due to adverse reactions
127 days
Other Outcomes (9)
Cmax (Maximum concentration)
127 days
Tmax (Time of maximum observed concentration)
127 days
T1/2 (Elimination half-life period)
127 days
- +6 more other outcomes
Study Arms (10)
Cohort 1
EXPERIMENTALSubjects in Cohort 1 will receive BCD-261 at a dose 1 during the Stage 1. Depending on the DLT, the cohort may include 1 to 3 subjects.
Cohort 2
EXPERIMENTALSubjects in Cohort 2 will receive BCD-261 at a dose 2 during the Stage 1. Depending on the DLT, the cohort may include 3 to 6 subjects.
Cohort 3
EXPERIMENTALSubjects in Cohort 3 will receive BCD-261 at a dose 3 during the Stage 1. Depending on the DLT, the cohort may include 3 to 6 subjects.
Cohort 4
EXPERIMENTALSubjects in Cohort 4 will receive BCD-261 at a dose 4 during the Stage 1. Depending on the DLT, the cohort may include 3 to 6 subjects.
Cohort 5
EXPERIMENTALSubjects in Cohort 5 will receive BCD-261 at a dose 5 during the Stage 1. Depending on the DLT, the cohort may include 3 to 6 subjects.
Cohort 6
EXPERIMENTALSubjects in Cohort 6 will receive BCD-261 at a dose 6 during the Stage 1. Depending on the DLT, the cohort may include 3 to 6 subjects.
Cohort 7
EXPERIMENTALSubjects in Cohort 7 will receive BCD-261 at a pre-specified proposed therapeautic dose X during the Stage 2. DLT events will not be assesed during the Stage 2. Cohort 7 will enroll 6 caucasian healthy subjects, who will recieve single subcutaneous injection of BCD-261 solution in vials.
Cohort 8
EXPERIMENTALSubjects in Cohort 8 will receive BCD-261 at a pre-specified proposed therapeautic dose X during the Stage 2. DLT events will not be assesed during the Stage 2. Cohort 8 will enroll 6 caucasian healthy subjects, who will recieve single subcutaneous injection of BCD-261 solution in pre-filled syringes.
Cohort 9
EXPERIMENTALSubjects in Cohort 9 will receive BCD-261 at a pre-specified proposed therapeautic dose X during the Stage 2. DLT events will not be assesed during the Stage 2. Cohort 9 will enroll about 10 asian healthy subjects, who will recieve single subcutaneous injection of BCD-261 solution in pre-filled syringes.
Cohort 10
EXPERIMENTALSubjects in Cohort 10 will receive BCD-261 at a pre-specified proposed therapeautic dose Y during the Stage 2. DLT events will not be assesed during the Stage 2. Cohort 10 will enroll about 10 asian healthy subjects, who will recieve single subcutaneous injection of BCD-261 solution in pre-filled syringes.
Interventions
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes
Eligibility Criteria
You may qualify if:
- Signed informed consent to participate in the study.
- For cohorts 1-8: Male subjects aged 18 to 45 years at the time of signing the ICF. For cohorts 9-10: Asian male subjects aged 18 to 45 years inclusive at the time of signing the ICF.
- The ability of the subject to follow the Protocol procedures, in the Investigator's opinion.
- A diagnosis of "healthy", established according to standard clinical, laboratory, and instrumental methods of examination carried out at screening, according to the assessment of the Investigator, as well as historical data (absence of acute and chronic diseases of the respiratory, cardiovascular, nervous systems, gastrointestinal tract, impaired liver or kidney function).
- Hemodynamic parameters within the normal range: systolic blood pressure (SBP) ranging 100 to 130 mmHg, diastolic (DBP) ranging 60 to 90 mmHg, pulse ranging 60 to 90 bpm at screening.
- Willingness of the subjects and their female partners of childbearing potential to use reliable contraceptive methods from the moment of signing the ICF, throughout the main study period, and up to Day 57 inclusive. This requirement does not apply to participants who have undergone surgical sterilization.
- Willingness of subjects with reproductive potential to refrain from donating sperm, starting from the moment of signing the ICF, throughout the main study period until Day 57 inclusive.
- Willingness to refrain from participating in any other clinical trials, starting from the moment of signing the ICF and throughout the study.
- Willingness to refrain from vaccination with any vaccines during the period from the moment of signing the ICF until Day 127 of the study inclusive.
You may not qualify if:
- Any medical or social condition that, in the opinion of the Investigator, prevents participation in this study.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition.
- Any acute infectious and non-infectious diseases, including the period of convalescence, within 4 weeks from the moment of clinical recovery to signing the ICF, as well as during screening.
- Diagnosis of infectious mononucleosis (documented or reported by the subject) within 2 months before signing the ICF and during screening.
- Vaccination with live vaccines within 8 weeks and with any other vaccines within 4 weeks prior to signing the ICF and during screening.
- A history of allergies and signs of other significant adverse reactions after the administration of any medicinal products.
- Hypersensitivity to the components of BCD-261.
- Body mass index (BMI) outside the normal range (18.0 to 30.0 kg/m2).
- Results of standard laboratory and instrumental tests outside the normal ranges adopted at the study site.
- Positive results of screening tests for HIV, hepatitis B and C, tuberculosis.
- Repeated positive urine drug test, repeated positive saliva alcohol test at screening.
- Impossibility of venipuncture for blood sampling (e.g., due to skin diseases at the sites of venipuncture).
- Administration and use of the following drugs:
- Regular oral or parenteral administration of any medicinal products, including over-the-counter drugs, vitamins, and dietary supplements, within less than 14 calendar days prior to estimated date of ID assignment.
- A history of using anti-TL1A monoclonal antibodies.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocadlead
Study Sites (1)
"Meditsinskiy teсhnologiy Maly"
Saint Petersburg, 197198, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Arina V Zinkina-Orikhan, PhD
Director of Clinical Development Department, BIOCAD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2024
First Posted
December 4, 2024
Study Start
March 29, 2024
Primary Completion
February 1, 2025
Study Completion
December 1, 2025
Last Updated
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share