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Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorBiocad

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BCD-261, dose 1

    Drug

    Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

  • BCD-261, dose 2

    Drug

    Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

  • BCD-261, dose 3

    Drug

    Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

  • BCD-261, dose 4

    Drug

    Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

  • BCD-261, dose 5

    Drug

    Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

  • BCD-261, dose 6

    Drug

    Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

  • BCD-261, pre-specified therapeautic dose X

    Drug

    Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

  • BCD-261, pre-specified therapeautic dose X

    Drug

    Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes

  • BCD-261, pre-specified therapeautic dose Y

    Drug

    Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes

Treatment groups

48 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Group E: Cohort 5Experimental treatment 1 intervention
Group F: Cohort 6Experimental treatment 1 intervention
Group G: Cohort 7Experimental treatment 1 intervention
Group H: Cohort 8Experimental treatment 1 intervention
Group I: Cohort 9Experimental treatment 1 intervention
Group J: Cohort 10Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects with adverse reactions

Time frame
127 days
2

Proportion of subjects with serious adverse reactions

Time frame
127 days
3

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

Time frame
127 days
4

Proportion of subjects who prematurely withdrew from the study due to adverse reactions

Time frame
127 days

Secondary outcomes

Other outcomes

1

Cmax (Maximum concentration)

Time frame
127 days
2

Tmax (Time of maximum observed concentration)

Time frame
127 days
3

T1/2 (Elimination half-life period)

Time frame
127 days
4

Kel (Elimination rate constant)

Time frame
127 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biocad

Lead sponsor

Source ClinicalTrials.gov
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