NCT05407779

Brief Summary

The aim of the study is to investigate the pharmacodynamics, pharmacokinetics, safety, and immunogenicity of BCD-180 after a single intravenous administration in escalating doses to healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2021

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

January 22, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

June 2, 2022

Last Update Submit

January 30, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects with adverse reactions

    361 days after the study drug administration for stage 1

  • Proportion of subjects with adverse reactions

    57 days after the study drug administration for stage 2

Other Outcomes (12)

  • Proportion of subjects with serious adverse reactions

    361 days after the study drug administration for stage 1

  • Proportion of subjects with serious adverse reactions

    57 days after the study drug administration for stage 2

  • Proportion of subjects with adverse reactions of grade 3 or higher according to CTCAE 5.0

    361 days after the study drug administration for stage 1

  • +9 more other outcomes

Study Arms (9)

Cohort 1

EXPERIMENTAL

The Cohort 1 include one subject ("sentinel volunteer") to receive BCD-180 at a dose 1

Biological: BCD-180, dose 1

Cohort 2

EXPERIMENTAL

The Cohort 2 include 3 subjects to receive BCD-180 at a dose 2

Biological: BCD-180, dose 2

Cohort 3

EXPERIMENTAL

The Cohort 3 include 3 subjects to receive BCD-180 at a dose 3

Biological: BCD-180, dose 3

Cohort 4

EXPERIMENTAL

The Cohort 4 include 3 subjects to receive BCD-180 at a dose 4

Biological: BCD-180, dose 4

Cohort 5

EXPERIMENTAL

The Cohort 5 include 3 subjects to receive BCD-180 at a dose 5

Biological: BCD-180, dose 5

Cohort 6

EXPERIMENTAL

The Cohort 6 include 3 subjects to receive BCD-180 at a dose 6

Biological: BCD-180, dose 6

Cohort 7

EXPERIMENTAL

The Cohort 7 include 3 subjects to receive BCD-180 at a dose 7

Biological: BCD-180, dose 7

Cohort 8

EXPERIMENTAL

The Cohort 8 include 3 subjects to receive BCD-180 at one of two selected for the further development doses

Biological: BCD-180, dose 6

Cohort 9

EXPERIMENTAL

The Cohort 9 include 3 subjects to receive BCD-180 at one of two selected for the further development doses

Biological: BCD-180, dose 7

Interventions

BCD-180, dose 1BIOLOGICAL

anti-TRBV9 monoclonal antibody single infusion at dose 1

Cohort 1
BCD-180, dose 2BIOLOGICAL

anti-TRBV9 monoclonal antibody, single infusion at dose 2

Cohort 2
BCD-180, dose 3BIOLOGICAL

anti-TRBV9 monoclonal antibody, single infusion at dose 3

Cohort 3
BCD-180, dose 4BIOLOGICAL

anti-TRBV9 monoclonal antibody, single infusion at dose 4

Cohort 4
BCD-180, dose 5BIOLOGICAL

anti-TRBV9 monoclonal antibody, single infusion at dose 5

Cohort 5
BCD-180, dose 6BIOLOGICAL

anti-TRBV9 monoclonal antibody, single infusion at dose 6

Cohort 6Cohort 8
BCD-180, dose 7BIOLOGICAL

anti-TRBV9 monoclonal antibody, single infusion at dose 7

Cohort 7Cohort 9

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed Informed consent form (ICF) for participation in the study.
  • Men aged 18 to 45 inclusive at the time of ICF signing.
  • For stage 2: Asian race.
  • The ability of the subject to follow the Protocol procedures, according to the investigator.
  • A diagnosis of "health" established using standard clinical, laboratory tests and investigations carried out at screening, according to the investigator, as well as medical history data (no acute or chronic respiratory, gastrointestinal, cardiovascular, nervous system diseases, hepatic or renal impairment).
  • Hemodynamic parameters within normal limits: systolic blood pressure (SBP) within 100-130 mm Hg, diastolic blood pressure (DBP) within 60-90 mm Hg, pulse rate within 60-90 bpm.
  • Willingness of subjects and their female sexual partners of childbearing potential to use reliable contraception from the ICF signing throughout the main period of the study and during Day 57 of the main period of the study. This requirement does not apply to subjects who have had surgical sterilization. Reliable methods of contraception involve the use of one barrier method in combination with one of the following in the female partner: spermicides, intrauterine device/oral contraceptives.
  • Willingness to refrain from participating in any other clinical trials, starting from the ICF signing, throughout the main study period and during Day 57 of the main study period, and in other clinical trials involving the administration of any drugs that affect the human immune system, including other monoclonal antibody products with immunosuppressive action, during the current study, i.e., until the end of participation in it.

You may not qualify if:

  • Any medical or social condition that, in the opinion of the investigator, precludes participation in this study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition.
  • Any acute infectious or non-infectious disease, including convalescence, less than 4 weeks from clinical recovery, as well as during the screening.
  • A diagnosis of infectious mononucleosis (either documented or reported by the subject) made within 2 months prior to the ICF signing or during the screening.
  • BCG (Bacillus Calmette-Guérin vaccine) vaccination (within 12 weeks), administration of live vaccines (within 8 weeks) or any other vaccines (within 4 weeks) before signing the ICF or during the screening.
  • Medical history of allergic reactions and evidence of other significant adverse reactions after administration of any medicinal products.
  • Hypersensitivity to any of the BCD-180 ingredients or premedication drugs.
  • Body mass index (BMI) outside of the normal range (18.0-30.0 kg/m2).
  • Results of standard laboratory and imaging tests that fall beyond the reference intervals adopted at the study center.
  • Positive screening tests for HIV infection, hepatitis B and C, syphilis, tuberculosis.
  • Positive urine test for psychotropic, narcotic, psychoactive drugs or saliva alcohol test at screening.
  • Impossibility of venipuncture to collect blood samples (for example, due to skin disease at venipuncture sites).
  • Long-term (more than 14 days) use of drugs that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before the ICF signing; prior use of drugs that affect the immune system, including other monoclonal antibody products, with immunosuppressive action.
  • Regular oral or parenteral administration of any medicinal products, including over-the-counter drugs, vitamins and dietary supplements, less than 14 days before the ICF signing.
  • Smoking more than 10 cigarettes a day.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

X7 Clinical Research

Saint Petersburg, Russia

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Stage 1. The first cohort will include one subject ("sentinel volunteer") who will receive BCD-180 at a dose 1. Starting from the 2nd cohort, the study will have a classic "3 + 3" design. Subjects will be monitored for 14 days following drug administration to assess the presence of dose limiting toxicity (DLT). In the absence of DLT, another cohort with a higher dose level will be formed. After all subjects have completed the main study period (Days 1-57), the safe dose range of BCD-180 will be determined based on assessed PD, PK, safety and immunogenicity endpoints. Further follow-up of the subjects included in stage 1 will continue up to a year. Stage 2. Two cohorts of healthy Asian volunteers (Cohorts 8 and 9) will be included. Subjects will receive a single infusion of BCD-180 at selected doses planned for further clinical development based on the results of the main period of stage 1.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

January 22, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

RU(1)