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HealthyPhase 1NCT05407779

Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 in Healthy Volunteers

A Phase 1 study testing BCD-180, dose 1, BCD-180, dose 2 and BCD-180, dose 3 in people with Healthy, run by Biocad at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BCD-180, dose 1, BCD-180, dose 2 and BCD-180, dose 3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteRussia
Study dates
22 Jan 2021to 30 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.
  • Consumption of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ L of beer, 200 mL of wine or 20 mL of spirits) or a history of alcoholism, drug addiction or drug abuse.
  • Surgical interventions performed less than 90 days before the ICF signing.
  • Donation of 450 mL or more of blood or plasma within 60 days prior to the ICF signing.
  • Participation in any clinical studies of medicinal products less than 90 days prior to the ICF signing; previous participation in this study in case of administration of the investigational product .
  • For stage 2: a history of coronavirus infection (positive polymerase chain reaction (PCR) test for SARC-CoV2-RNA) within 8 weeks prior to the ICF signing.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • X7 Clinical Research

    Saint Petersburg

Other trials in Russia

About this study

Official title: An Open-Label, Non-controlled Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 (JSC BIOCAD, Russia) in Healthy Volunteers

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.

Read the detailed description

The study will be carried out in 2 stages. Stage 1 involves administration of escalating doses of study drug (BCD-180) in 7 cohorts of healthy subjects. The first cohort will include one subject ("sentinel volunteer"). Each of the subsequent cohorts will include 3 subjects, each of whom will receive a preset cohort dose of BCD-180 as a single intravenous infusion. Stage 2: additionally 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.

Conditions
Healthy
Being tested
BCD-180, dose 1, BCD-180, dose 2, BCD-180, dose 3, BCD-180, dose 4, BCD-180, dose 5

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-180, dose 1Biological

    anti-TRBV9 monoclonal antibody single infusion at dose 1

  • BCD-180, dose 2Biological

    anti-TRBV9 monoclonal antibody, single infusion at dose 2

  • BCD-180, dose 3Biological

    anti-TRBV9 monoclonal antibody, single infusion at dose 3

  • BCD-180, dose 4Biological

    anti-TRBV9 monoclonal antibody, single infusion at dose 4

  • BCD-180, dose 5Biological

    anti-TRBV9 monoclonal antibody, single infusion at dose 5

  • BCD-180, dose 6Biological

    anti-TRBV9 monoclonal antibody, single infusion at dose 6

  • BCD-180, dose 7Biological

    anti-TRBV9 monoclonal antibody, single infusion at dose 7

Study groups in NCT05407779
Study groupRoleWhat they receive
Cohort 1ExperimentalThe Cohort 1 include one subject ("sentinel volunteer") to receive BCD-180 at a dose 1
Receives: Biological: BCD-180, dose 1
Cohort 2ExperimentalThe Cohort 2 include 3 subjects to receive BCD-180 at a dose 2
Receives: Biological: BCD-180, dose 2
Cohort 3ExperimentalThe Cohort 3 include 3 subjects to receive BCD-180 at a dose 3
Receives: Biological: BCD-180, dose 3
Cohort 4ExperimentalThe Cohort 4 include 3 subjects to receive BCD-180 at a dose 4
Receives: Biological: BCD-180, dose 4
Cohort 5ExperimentalThe Cohort 5 include 3 subjects to receive BCD-180 at a dose 5
Receives: Biological: BCD-180, dose 5
Cohort 6ExperimentalThe Cohort 6 include 3 subjects to receive BCD-180 at a dose 6
Receives: Biological: BCD-180, dose 6
Cohort 7ExperimentalThe Cohort 7 include 3 subjects to receive BCD-180 at a dose 7
Receives: Biological: BCD-180, dose 7
Cohort 8ExperimentalThe Cohort 8 include 3 subjects to receive BCD-180 at one of two selected for the further development doses
Receives: Biological: BCD-180, dose 6
Cohort 9ExperimentalThe Cohort 9 include 3 subjects to receive BCD-180 at one of two selected for the further development doses
Receives: Biological: BCD-180, dose 7

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with adverse reactions

    Measured: 361 days after the study drug administration for stage 1

  2. Proportion of subjects with adverse reactions

    Measured: 57 days after the study drug administration for stage 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study start22 Jan 2021
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05407779
Sponsor's protocol ID
BCD-180-1
Status last verified
Jan 2024
First submitted
2 Jun 2022
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCD-180, dose 1, BCD-180, dose 2 and BCD-180, dose 3 in people with Healthy, run by Biocad at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with adverse reactions (time frame: 361 days after the study drug administration for stage 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05407779.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

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