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

NCT02380287 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-03-03

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

humanized monoclonal antibody against human IL-17

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Roman Ivanov, PhD · JCS BIOCAD

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-09-30
Completion
2015-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02380287 on ClinicalTrials.gov