HealthyPhase 1NCT03103438

First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects

A Phase 1 study testing BCD-089 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.

Trial summary

This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against the interleukin-6 receptor - BCD-089. The study will enroll 19 healthy male volunteers. 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-089
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteRussia
Study dates: Nov 2016to May 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

singed informed consent
male gender
18-45 years of age inclusively
BMI between18.5-30.0 kg/sq.m.
absence of any sings of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis
parameters of complete blood count, blood biochemistry, and urinalysis do not exceed reference values, which are used at Study site laboratory

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normal hemodynamic parameters :
absence of chronic infections (HIV, syphilis, hepatitis В or С, tuberculosis ) and chronic inflammation
absence of infections within 4 weeks before screening
absence of mental disorders or other conditions, which may affect the ability of participant to follow Protocol
absence of alcohol or drug addiction signs (incl. history of such addiction).
volunteer's ability to follow Protocol procedures
consent of volunteers and their sexual partners with childbearing potential to use adequate contraception during screening period and the main study part (14 days before randomization and 70 day after SC injection). This requirement is not applicable in surgically sterilized volunteers. Adequate contraception includes the use of one barrier method in combination with spermicides, intrauterine device / oral contraceptives in sexual partner

Who cannot join

history of use of monoclonal antibodies against IL-6 or IL-6R
known severe allergy (anaphylaxis or multidrug intolerance)
known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-089
major surgery within 30 days prior screening
severe infections (required hospitalization, parenteral use of antimicrobial agents) within 6 months prior the date of BCD-089 injection
systemic use of antimicrobials within 2 months prior the date of BCD-089 injection

Show all 12Show fewer

more than 4 episodes of respiratory tract infections within 6 months prior the screening examination
presence of any disorders which may affect pharmacokinetics of BCD-089
history of fever which was equal or exceeded 40 degrees in Celsius
- actual or prior depression, suicidal tendencies
use of any medicines, vitamins, biologically active additives within 14 days prior the screening examination use of any medicines which affects hemodynamics or hepatic function within 30 days prior the screening examination simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 2 months before this study initiation.
previous participation in this study

Trial locations and contacts

1 site in 1 country.

Russia1 site

LLC BioEk
Saint Petersburg

Other trials in Russia

About this study

Official title: An Open-Label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of BCD-089 in Healthy Volunteers

Read the detailed description

IL-6 is a new potential therapeutic target which plays important role in pathogenesis of several autoimmune disorders including rheumatoid arthritis. BCD-089 is a novel fully human monoclonal antibody against the interleukin-6 receptor developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-089-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of BCD-089 when used as a single step-by-step escalating subcutaneous dose in healthy male volunteers. During this study it is expected to determine diapason of safety doses of BCD-089 (incl. MTD) which thereafter can be evaluated in phase 2 studies.

Conditions: Healthy
Being tested: BCD-089

What participants receive

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

BCD-089Biological
Also called human monoclonal antibody to interleukin-6 receptor

Study groups in NCT03103438
Study group	Role	What they receive
Cohort 1	Experimental	his cohort includes one subject who will receive the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included. Receives: Biological: BCD-089
Cohort 2	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no.3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3. Receives: Biological: BCD-089
Cohort 3	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4. Receives: Biological: BCD-089
Cohort 4	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5. Receives: Biological: BCD-089
Cohort 5	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6. Receives: Biological: BCD-089
Cohort 6	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7. Receives: Biological: BCD-089
Cohort 7	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. Receives: Biological: BCD-089

What is being measured

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

Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089
Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089.
Measured: 70 days

Timeline

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

Nov 2016May 2017

First posted6 Apr 2017
Study startNov 2016
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03103438
Sponsor's protocol ID: BCD-089-1
Status last verified: Feb 2021
First submitted: 24 Mar 2017
Last updated: 26 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of BCD-089 in Healthy Volunteers
ClinicalTrials.gov ID: NCT03103438
Acronym / sponsor ID: BCD-089-1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: Nov 2016 (actual)
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 6 Apr 2017 (actual)
Results: Posted 26 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Cohort 1	Experimental	Biological: BCD-089his cohort includes one subject who will receive the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included.
Cohort 2	Experimental	Biological: BCD-089This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no.3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3.
Cohort 3	Experimental	Biological: BCD-089This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4.
Cohort 4	Experimental	Biological: BCD-089This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5.
Cohort 5	Experimental	Biological: BCD-089This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6.
Cohort 6	Experimental	Biological: BCD-089This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7.
Cohort 7	Experimental	Biological: BCD-089This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

singed informed consent
male gender
18-45 years of age inclusively
BMI between18.5-30.0 kg/sq.m.
absence of any sings of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis

Key exclusion criteria (12 listed)

history of use of monoclonal antibodies against IL-6 or IL-6R
known severe allergy (anaphylaxis or multidrug intolerance)
known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-089
major surgery within 30 days prior screening
severe infections (required hospitalization, parenteral use of antimicrobial agents) within 6 months prior the date of BCD-089 injection

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-089Also: human monoclonal antibody to interleukin-6 receptor	Biological	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7

Primary outcome

Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089
Time frame: 70 days
Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089.

Results and safety

Results posted to the registry on 26 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	1	1
Cohort 2	3	3
Cohort 3	3	3
Cohort 4	3	3
Cohort 5	3	3
Cohort 6	3	3
Cohort 7	3	3

Primary outcome: Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089

Time frame: 70 days. Median (Inter-Quartile Range). Unit: ng/ml*h

Measure	Cohort 1 n = 1	Cohort 2 n = 3	Cohort 3 n = 3	Cohort 4 n = 3	Cohort 5 n = 3	Cohort 6 n = 3	Cohort 7 n = 3
Value	0 (0 to 0)	15567.9 (8364.0 to 18664.2)	44568.6 (14441.2 to 50635.4)	588202.2 (160711.0 to 1044464.2)	1208489.2 (777536.3 to 1352794.3)	4190342.2 (3891917.6 to 6676172.8)	10512592.4 (8628174.9 to 10759494.4)

Population analysed: The pharmacokinetic analysis population included the data from all volunteers included in the study (n = 19).

Adverse events

Time frame: 71 days from the moment of injection. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Cohort 2	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort 3	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort 4	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort 5	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cohort 6	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Cohort 7	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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-089 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 13 inclusion and 12 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 26 Feb 2021. 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?

Yes. Results are posted in the registry (first posted 26 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089 (time frame: 70 days). 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 NCT03103438.

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 26 Feb 2021.