A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers

CSL Behring78 enrolled

Overview

This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

Human beta common receptor antagonist monoclonal antibodyBIOLOGICAL

Human beta common receptor antagonist monoclonal antibody

PlaceboDRUG

0.9% sodium chloride, same volume and same duration as CSL311

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects 18 to 65 years of age with diagnosis of mild-to-moderate asthma for Parts A and B. For part C healthy, male or female subjects 18 to 50 years Exclusion Criteria: * Oral/parenteral corticosteroids or anti-interleukin-6 therapy within 6 months prior to screening, or any prohibited therapies prior to screening. * History or presence of clinically significant hypertension or other significant cardiovascular abnormality. * Any clinically significant abnormality on electrocardiogram at screening. * Parasitic infestation within 6 months before screening, or travel or intention to travel to a country with a high prevalence of such infections within 1 year before screening or within 85 days after the last dose of CSL311. * Occurrence of asthma exacerbation and/or upper/lower respiratory tract infection, or any acute infection or disease within the last 6 weeks before screening.

Locations (3)

Paraxel Berlin

Berlin, Germany

Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM

Hanover, Germany

Medicines Evaluation Unit

Manchester, United Kingdom

Outcomes

Primary Outcomes

Percentage of subjects with treatment-emergent adverse events (TEAEs) in SC single dose, single ascending doses (SAD) and multiple ascending doses (MAD - SC and IV)

Time frame: After infusion or injection, up to Day 85 for Cohorts A1 to A7, Day 57 for Cohort A8, Day 114 for Cohort B1 and Day 85 for Cohorts C1 to C3

Percentage of subjects with related TEAEs in SC single dose, SAD and MAD (SC and IV)

Time frame: After infusion or injection, up to Day 85 for Cohorts A1 to A7, Day 57 for Cohort A8, Day 114 for Cohort B1 and Day 85 for Cohorts C1 to C3

Percentage of subjects with TEAEs by severity in SC single dose, SAD and MAD (SC and IV)

Severity of TEAEs defined as mild, moderate, or severe

Time frame: After infusion or injection, up to Day 85 for Cohorts A1 to A7, Day 57 for Cohort A8, Day 114 for Cohort B1 and Day 85 for Cohorts C1 to C3