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First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-121 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03103451
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Biocad

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BCD-121 Other: Placebo Phase 1

Detailed Description:
Simultaneous blockade of IL-17 and TNFa is a potential therapeutic way of treatment of several autoimmune disorders. BCD-121 is a novel humanized monoclonal bispecific antibody against human IL17 and TNFa developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-121-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of BCD-121 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-121 (incl. MTD) which thereafter can be evaluated in phase 2 studies.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Cohort 1

This cohort includes 3 subjects in BCD-121 group and 1 subject in placebo group.

Intervention: BCD-121/ placebo

Drug: BCD-121
Other Name: monoclonal bispecific antibody against human IL-17/ TNFa

Other: Placebo
Experimental: Cohort 2

This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.

Intervention: BCD-121/ placebo

Drug: BCD-121
Other Name: monoclonal bispecific antibody against human IL-17/ TNFa

Other: Placebo
Experimental: Cohort 3

This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.

Intervention: BCD-121/ placebo

Drug: BCD-121
Other Name: monoclonal bispecific antibody against human IL-17/ TNFa

Other: Placebo
Experimental: Cohort 4

This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.

Intervention: BCD-121/ placebo

Drug: BCD-121
Other Name: monoclonal bispecific antibody against human IL-17/ TNFa

Other: Placebo
Experimental: Cohort 5

This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.

Intervention: BCD-121/ placebo

Drug: BCD-121
Other Name: monoclonal bispecific antibody against human IL-17/ TNFa

Other: Placebo
Experimental: Cohort 6

This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.

Intervention: BCD-121/ placebo

Drug: BCD-121
Other Name: monoclonal bispecific antibody against human IL-17/ TNFa

Other: Placebo
Experimental: Cohort 7

This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.

Intervention: BCD-121/ placebo

Drug: BCD-121
Other Name: monoclonal bispecific antibody against human IL-17/ TNFa

Other: Placebo



Primary Outcome Measures :
  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 [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Maximum Concentration of BCD-121 After Single Subcutaneous Injection [ Time Frame: 90 days ]
  2. Time to Maximum Concentration of BCD-121 After Single Subcutaneous Injection [ Time Frame: 90 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.
  • previous participation in this study

Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT03103451     History of Changes
Other Study ID Numbers: BCD-121-1
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs