HealthyPhase 1NCT02380287

First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects

A Phase 1 study testing humanized monoclonal antibody against human IL-17 in people with Healthy, run by Biocad.

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 and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against human IL-17 - BCD-085. The study will enroll 37 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?: humanized monoclonal antibody against human IL-17
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: No sites listed yet
Study dates: Mar 2015to Oct 2015
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. Evaluation of required laboratory parameters must be performed within 14 days before randomization

Show all 14Show fewer

normal hemodynamic parameters : systolic BP 100 - 139 mm Hg, diastolic BP - 60 - 90 mm Hg, heart rate - 60 - 90 b/min
absence of chronic infections (HIV, syphilis, hepatitis В or С, tuberculosis ) and chronic inflammation
absence of infections within 4 weeks before randomization
absence of mental disorders or other conditions (incl. depression), which may affect the ability of participant to follow Protocol
health well-being (by volunteer's opining opinion) for at least 30 days before randomization.
absence of alcohol or drug addiction signs (incl. history of such addiction). Consent not to use alcohol within 24 hours before and after injection of BCD-085;
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 61 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-17
known severe allergy (anaphylaxis or multidrug intolerance)
known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-085
major surgery within 30 days prior screening
severe infections (required hospitalization, parenteral use of antimicrobial agents) within 6 months prior the date of BCD-085 injection
systemic use of antimicrobials within 2 months prior the date of BCD-085 injection

Show all 21Show 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-085
history of fever which was equal or exceeded 40 degrees in Celsius
history of hepatic transaminases increase 2.5 x ULN
history of seizures
actual or prior depression, suicidal tendencies
use of any medicines, vitamins, biologically active additives within 14 days prior the date of BCD-085 injection
use of any medicines which affects hemodynamics or hepatic function within 30 days prior the date of BCD-085 injection
use of any medicines which may influence on immune system within 30 days prior the date of BCD-085 injection
vaccination within 4 weeks prior the date of BCD-085 injection
smoking exceeds 10 cigarettes per day
use of alcohol, which exceeds 10 units per week (1 alcohol unit is equal ½ l of beer (1 pint), or 200 ml of vine, or 50 ml alcohol
donation of more than 450 ml of blood or plasma within 2 months prior randomization.
simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation.
previous participation in this study

About this study

Official title: Open-label, Phase I Dose-escalation Clinical Study of the Safety, Tolerability and Pharmacokinetics of Single Subcutaneus Dose of BCD-085, Monoclonal Antibody Against IL-17, in Healthy Subjects

Read the detailed description

IL-17 is a new potential therapeutic target which plays important role in pathogenesis of several autoimmune disorders including psoriasis, rheumatoid arthritis, possibly - SLE and MS. BCD-085 is a novel humanized monoclonal antibody against human IL17 developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-085-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics and immunogenicity of BCD-085 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-085 (incl. MTD) which thereafter can be evaluated in phase 2 studies.

Conditions: Healthy
Being tested: humanized monoclonal antibody against human IL-17
Keywords: interleukin-17, maximum tolerated dose, novel monoclonal antibody

What participants receive

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

humanized monoclonal antibody against human IL-17Drug
Also called BCD-085

Study groups in NCT02380287
Study group	Role	What they receive
Cohort no.1	Experimental	This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 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: Drug: humanized monoclonal antibody against human IL-17
Cohort no.2	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 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: Drug: humanized monoclonal antibody against human IL-17
Cohort no.3	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 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: Drug: humanized monoclonal antibody against human IL-17
Cohort no.4	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 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: Drug: humanized monoclonal antibody against human IL-17
Cohort no.5	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 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: Drug: humanized monoclonal antibody against human IL-17
Cohort no.6	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 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: Drug: humanized monoclonal antibody against human IL-17
Cohort no.7	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 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. 8 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. 8. Receives: Drug: humanized monoclonal antibody against human IL-17
Cohort no.8	Experimental	This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 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 exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. Receives: Drug: humanized monoclonal antibody against human IL-17

What is being measured

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

Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085
The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 h (5 min before the injection) and at 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours,168 hours, 336 hours, 504 hours, 672 hours, 840 hours, 1008 hours, 1176 hours, and 1344 hours following the drug administration.
Measured: 56 days

Secondary outcomes (1)

Maximum Concentration of BCD-085 After Single Subcutaneous Injection
To assess the maximum observed concentration (Cmax) following single SC administer regardless of the cohort
Measured: 56 days

Timeline

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

Mar 2015Oct 2015

First posted5 Mar 2015 (estimated)
Study startMar 2015
Primary completionSep 2015
Study completionOct 2015

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: Sequential
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02380287
Sponsor's protocol ID: BCD-085-1
Status last verified: Feb 2021
First submitted: 2 Mar 2015
Last updated: 3 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

Official record

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Phase I Dose-escalation Clinical Study of the Safety, Tolerability and Pharmacokinetics of Single Subcutaneus Dose of BCD-085, Monoclonal Antibody Against IL-17, in Healthy Subjects
ClinicalTrials.gov ID: NCT02380287
Acronym / sponsor ID: BCD-085-1
Conditions: Healthy
Keywords: interleukin-17, maximum tolerated dose, novel monoclonal antibody
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Sep 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 5 Mar 2015 (estimated)
Results: Posted 23 May 2016

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: Sequential
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Cohort no.1	Experimental	Drug: humanized monoclonal antibody against human IL-17This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 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 no.2	Experimental	Drug: humanized monoclonal antibody against human IL-17This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 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 no.3	Experimental	Drug: humanized monoclonal antibody against human IL-17This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 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 no.4	Experimental	Drug: humanized monoclonal antibody against human IL-17This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 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 no.5	Experimental	Drug: humanized monoclonal antibody against human IL-17This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 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 no.6	Experimental	Drug: humanized monoclonal antibody against human IL-17This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 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 no.7	Experimental	Drug: humanized monoclonal antibody against human IL-17This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 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. 8 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. 8.
Cohort no.8	Experimental	Drug: humanized monoclonal antibody against human IL-17This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 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 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 (14 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 (21 listed)

history of use of monoclonal antibodies against IL-17
known severe allergy (anaphylaxis or multidrug intolerance)
known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-085
major surgery within 30 days prior screening
severe infections (required hospitalization, parenteral use of antimicrobial agents) within 6 months prior the date of BCD-085 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
humanized monoclonal antibody against human IL-17Also: BCD-085	Drug	Cohort no.1, Cohort no.2, Cohort no.3, Cohort no.4, Cohort no.5, Cohort no.6, Cohort no.7, Cohort no.8

Primary outcome

Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085
Time frame: 56 days
The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 h (5 min before the injection) and at 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours,168 hours, 336 hours, 504 hours, 672 hours, 840 hours, 1008 hours, 1176 hours, and 1344 hours following the drug administration.

1 secondary outcome

Maximum Concentration of BCD-085 After Single Subcutaneous Injection
Time frame: 56 days

Results and safety

Results posted to the registry on 23 May 2016, 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 no.1	1	1
Cohort no.2	3	3
Cohort no.3	3	2
Cohort no.4	3	3
Cohort no.5	3	3
Cohort no.6	3	3
Cohort no.7	3	3
Cohort no.8	3	3

Primary outcome: Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085

Time frame: 56 days. Median (Inter-Quartile Range). Unit: (ng/ml)*hour

Measure	Cohort 1 + Cohort 2 n = 4	Cohort 3 n = 2	Cohort 4 n = 3	Cohort 5 n = 3	Cohort 6 n = 3	Cohort 7 n = 3	Cohort 8 n = 3
Value	594222.00 (583105.25 to 597706.25)	2262670.25 (1600708.75 to 2924631.75)	5669903.75 (5566847.00 to 7958067.25)	9939951.75 (8169096.25 to 10963413.25)	9220825.00 (6191133.50 to 11536130.00)	14915081.50 (13047990.50 to 14963820.50)	10152522550.50 (9119054864.00 to 11931556230.00)

Population analysed: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort no.1	0 of 1 (0%)	1 of 1 (100%)	Not reported
Cohort no.2	0 of 3 (0%)	0 of 3 (0%)	Not reported
Cohort no.3	1 of 3 (33.3%)	1 of 3 (33.3%)	Not reported
Cohort no.4	0 of 3 (0%)	0 of 3 (0%)	Not reported
Cohort no.5	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Cohort no.6	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Cohort no.7	0 of 3 (0%)	0 of 3 (0%)	Not reported
Cohort no.8	0 of 3 (0%)	0 of 3 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 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.

Roman Ivanov, PhD study chair

JCS BIOCAD

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing humanized monoclonal antibody against human IL-17 in people with Healthy, run by Biocad.

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 14 inclusion and 21 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

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 23 May 2016). 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-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085 (time frame: 56 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 NCT02380287.

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 3 Mar 2021.