First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-121 in Healthy Subjects
A Comparative Randomized Single-Blind Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Single Escalating Subcutaneous Doses of BCD 121 in Healthy Volunteers
1 other identifier
interventional
28
0 countries
N/A
Brief Summary
This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal bispecific antibody against human IL-17/TNFa. The study will enroll 28 healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Nov 2016
Typical duration for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 27, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJuly 17, 2017
March 1, 2017
6 months
March 27, 2017
July 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area Under the Plasma Concentration of BCD-121-time Curve From Zero (0) Hours to 2160 Hours After the Single Subcutaneous Injection of BCD-121
90 days
Secondary Outcomes (2)
Maximum Concentration of BCD-121 After Single Subcutaneous Injection
90 days
Time to Maximum Concentration of BCD-121 After Single Subcutaneous Injection
90 days
Study Arms (7)
Cohort 1
EXPERIMENTALThis cohort includes 3 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo
Cohort 2
EXPERIMENTALThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo
Cohort 3
EXPERIMENTALThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo
Cohort 4
EXPERIMENTALThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo
Cohort 5
EXPERIMENTALThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo
Cohort 6
EXPERIMENTALThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo
Cohort 7
EXPERIMENTALThis cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group. Intervention: BCD-121/ placebo
Interventions
Eligibility Criteria
You may qualify if:
- singed informed consent
- male gender
- 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
- normal hemodynamic parameters
- 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)
- volunteer's ability to follow Protocol procedures
- consent of volunteers and their sexual partners with childbearing potential to use adequate contraception
You may not qualify if:
- history of use of monoclonal antibodies against IL-17 or TNFa
- known severe allergy (anaphylaxis or multidrug intolerance)
- known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-121/placebo
- major surgery within 30 days prior screening
- severe infections (required hospitalization, parenteral use of antimicrobial agents)
- systemic use of antimicrobials
- more than 4 episodes of respiratory tract infections within 6 months prior the screening
- presence of any disorders which may affect pharmacokinetics of BCD-121
- 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-121 injection
- simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocadlead
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2017
First Posted
April 6, 2017
Study Start
November 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
July 17, 2017
Record last verified: 2017-03