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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103451
• Other study ID #: BCD-121-1
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2017
• Last updated: July 14, 2017
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: March 2017
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 ? or ?, 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BCD-121

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Concentration of BCD-121 After Single Subcutaneous Injection		90 days
Secondary	Time to Maximum Concentration of BCD-121 After Single Subcutaneous Injection		90 days