HealthyPhase 1NCT06715540
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
A Phase 1 study testing BCD-261, dose 1, BCD-261, dose 2 and BCD-261, dose 3 in people with Healthy, run by Biocad at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BCD-261, dose 1, BCD-261, dose 2 and BCD-261, dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteRussia
- Study dates
- 29 Mar 2024to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
- Taking medications, including over-the-counter drugs, that have a pronounced effect on hemodynamics and liver function (barbiturates, omeprazole, cimetidine, etc.), within less than 30 days before the estimated date of ID assignment.
- Taking drugs that affect the immune status (cytokines and their inducers, glucocorticoids, etc.) within less than 60 days before the estimated date of ID assignment.
- Smoking of 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 within 90 days before the signing of the ICF.
- Donation of 450 mL or more of blood or plasma within 60 days prior to signing the ICF.
- Participation in any clinical study of medicinal products within 90 days before signing the ICF; previous participation in the same study with the exception of subjects who withdrew before the administration of the investigational product.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
"Meditsinskiy teсhnologiy Maly"
Saint Petersburg, 197198
Ivan S Sardaryan, MD, PhD
About this study
Official title: 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
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).
Read the detailed description
The study is conducted in 2 stages. During the Stage 1 of the study, dose escalation is performed in several cohorts to assess the effects of dose-limiting toxicity (DLT), the maximum tolerated dose of BCD-261.
During the dose escalation one subject ("sentinel volunteer") will be included in cohort 1. Starting from the 2nd cohort and up to the 6th cohort, the study is planned within a classic "3+3" design.
Based on the results of the analysis of the Stage 1 data, including the assessment of safety, pharmacodynamics, pharmacokinetics, immunogenicity of BCD-261, a decision will be made on the possibility of switching to the Stage 2 of the study (dose expansion).
DLT events will be monitored for 7 days after BCD-261 injection (during Stage 1), and may include any of CTCAE 5.0 grade ≥3 adverse events that are at least possibly related to the study drug.
During the Stage 2 an extended study of the safety, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 at two pre-selected proposed therapeutic doses, is carried out with the inclusion of several additional cohorts of healthy caucasians and asians.
- Conditions
- Healthy
- Being tested
- BCD-261, dose 1, BCD-261, dose 2, BCD-261, dose 3, BCD-261, dose 4, BCD-261, dose 5
- Keywords
- anti-TL1A, anti-TNF-like ligand 1A, Ulcerative Colitis, Inflammatory Bowel Disease, Crohn's Disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-261, dose 1Drug
Also called anti-TL1A
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
BCD-261, dose 2Drug
Also called anti-TL1A
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
BCD-261, dose 3Drug
Also called anti-TL1A
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
BCD-261, dose 4Drug
Also called anti-TL1A
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
BCD-261, dose 5Drug
Also called anti-TL1A
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
BCD-261, dose 6Drug
Also called anti-TL1A
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
BCD-261, pre-specified therapeautic dose XDrug
Also called anti-TL1A
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
BCD-261, pre-specified therapeautic dose XDrug
Also called anti-TL1A
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes
BCD-261, pre-specified therapeautic dose YDrug
Also called anti-TL1A
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects 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. Receives: Drug: BCD-261, dose 1 |
| Cohort 2 | Experimental | Subjects 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. Receives: Drug: BCD-261, dose 2 |
| Cohort 3 | Experimental | Subjects 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. Receives: Drug: BCD-261, dose 3 |
| Cohort 4 | Experimental | Subjects 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. Receives: Drug: BCD-261, dose 4 |
| Cohort 5 | Experimental | Subjects 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. Receives: Drug: BCD-261, dose 5 |
| Cohort 6 | Experimental | Subjects 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. Receives: Drug: BCD-261, dose 6 |
| Cohort 7 | Experimental | Subjects 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. Receives: Drug: BCD-261, pre-specified therapeautic dose X |
| Cohort 8 | Experimental | Subjects 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. Receives: Drug: BCD-261, pre-specified therapeautic dose X |
| Cohort 9 | Experimental | Subjects 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. Receives: Drug: BCD-261, pre-specified therapeautic dose X |
| Cohort 10 | Experimental | Subjects 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. Receives: Drug: BCD-261, pre-specified therapeautic dose Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with adverse reactions
Measured: 127 days
Proportion of subjects with serious adverse reactions
Measured: 127 days
Proportion of subjects with CTCAE 5.0 grade 3 or higher adverse reactions
Measured: 127 days
Proportion of subjects who prematurely withdrew from the study due to adverse reactions
Measured: 127 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start29 Mar 2024
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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: "3+3" design (dose escalation). Stage 2: parallel arms (dose expansion)
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arina V Zinkina-Orikhan, PhD, Study director, Director of Clinical Development Department, BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715540
- Sponsor's protocol ID
- BCD-261-1
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06715540
- Acronym / sponsor ID
- BCD-261-1
- Conditions
- Healthy
- Keywords
- anti-TL1A, anti-TNF-like ligand 1A, Ulcerative Colitis, Inflammatory Bowel Disease, Crohn's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study is conducted in 2 stages. During the Stage 1 of the study, dose escalation is performed in several cohorts to assess the effects of dose-limiting toxicity (DLT), the maximum tolerated dose of BCD-261.
During the dose escalation one subject ("sentinel volunteer") will be included in cohort 1. Starting from the 2nd cohort and up to the 6th cohort, the study is planned within a classic "3+3" design.
Based on the results of the analysis of the Stage 1 data, including the assessment of safety, pharmacodynamics, pharmacokinetics, immunogenicity of BCD-261, a decision will be made on the possibility of switching to the Stage 2 of the study (dose expansion).
DLT events will be monitored for 7 days after BCD-261 injection (during Stage 1), and may include any of CTCAE 5.0 grade ≥3 adverse events that are at least possibly related to the study drug.
During the Stage 2 an extended study of the safety, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 at two pre-selected proposed therapeutic doses, is carried out with the inclusion of several additional cohorts of healthy caucasians and asians.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
- Model description
- Stage 1: "3+3" design (dose escalation). Stage 2: parallel arms (dose expansion)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BCD-261, dose 1Subjects 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 | Experimental | Drug: BCD-261, dose 2Subjects 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 | Experimental | Drug: BCD-261, dose 3Subjects 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 | Experimental | Drug: BCD-261, dose 4Subjects 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 | Experimental | Drug: BCD-261, dose 5Subjects 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 | Experimental | Drug: BCD-261, dose 6Subjects 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 | Experimental | Drug: BCD-261, pre-specified therapeautic dose XSubjects 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 | Experimental | Drug: BCD-261, pre-specified therapeautic dose XSubjects 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 | Experimental | Drug: BCD-261, pre-specified therapeautic dose XSubjects 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 | Experimental | Drug: BCD-261, pre-specified therapeautic dose YSubjects 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-261, dose 1Also: anti-TL1AAnti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials | Drug | Cohort 1 |
| BCD-261, dose 2Also: anti-TL1AAnti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials | Drug | Cohort 2 |
| BCD-261, dose 3Also: anti-TL1AAnti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials | Drug | Cohort 3 |
| BCD-261, dose 4Also: anti-TL1AAnti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials | Drug | Cohort 4 |
| BCD-261, dose 5Also: anti-TL1AAnti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials | Drug | Cohort 5 |
| BCD-261, dose 6Also: anti-TL1AAnti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials | Drug | Cohort 6 |
| BCD-261, pre-specified therapeautic dose XAlso: anti-TL1AAnti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials | Drug | Cohort 7 |
| BCD-261, pre-specified therapeautic dose XAlso: anti-TL1AAnti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes | Drug | Cohort 8, Cohort 9 |
| BCD-261, pre-specified therapeautic dose YAlso: anti-TL1AAnti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes | Drug | Cohort 10 |
Primary outcome
Proportion of subjects with adverse reactions
Time frame: 127 days
Proportion of subjects with serious adverse reactions
Time frame: 127 days
Proportion of subjects with CTCAE 5.0 grade 3 or higher adverse reactions
Time frame: 127 days
Proportion of subjects who prematurely withdrew from the study due to adverse reactions
Time frame: 127 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Clinical Trials \| BIOCADLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arina V Zinkina-Orikhan, PhD study director
Director of Clinical Development Department, BIOCAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCD-261, dose 1, BCD-261, dose 2 and BCD-261, 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 9 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 16 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yulia E Tsarikhina, MD (+7 (981) 698 14 22, tsarikhina@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with adverse reactions (time frame: 127 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.