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 Behring

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Biological: Human beta common receptor antagonist monoclonal antibody; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04082754

2019-001135-32 (EudraCT Number)

CSL311_1001

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 14 patient groups, including a placebo group

CSL311 Cohort A1 (SAD Dose 1)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered intravenously at a Single Ascending Dose (SAD)

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort A2 (SAD Dose 2)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort A3 (SAD Dose 3)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort A4 (SAD Dose 4)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort A5 (SAD Dose 5)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort A6 (SAD Dose 6)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort A7 (SAD Dose 7)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort A8 (SAD Dose 8)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort B1 (MAD Dose 1)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered intravenously at a MAD

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

Placebo

Placebo Comparator group

Description:

0.9% sodium chloride solution administered intravenously

Treatment:

Drug: Placebo

Placebo (2)

Placebo Comparator group

Description:

0.9% sodium chloride solution administered subcutaneously

Treatment:

Drug: Placebo

CSL311 Cohort C1 (MAD Dose 1)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered subcutaneously (SC)

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort C2 (MAD Dose 2)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered subcutaneously

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody

CSL311 Cohort C3 (MAD Dose 3)

Experimental group

Description:

Human beta common receptor antagonist monoclonal antibody administered subcutaneously

Treatment:

Biological: Human beta common receptor antagonist monoclonal antibody