Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults

NCT ID: NCT03375606

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2020-06-22

Brief Summary

To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

CSL730

Group Type: EXPERIMENTAL

CSL730

Intervention Type: BIOLOGICAL

Solution for IV infusion

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Saline solution for IV infusion

Interventions

CSL730

Solution for IV infusion

Intervention Type: BIOLOGICAL

Placebo

Saline solution for IV infusion

Intervention Type: OTHER

Other Intervention Names

Recombinant trivalent human IgG1 Fc multimer

Eligibility Criteria

Inclusion Criteria

• Healthy males or females (postmenopausal or surgically sterile only) aged ≥ 20 to ≤ 55 years and of Caucasian or Japanese descent

Exclusion Criteria

• Evidence of a clinically significant medical condition, disorder, or disease as judged by Investigator and / or study Medical Monitor.
• History of asthma (with the exception of childhood asthma that has resolved), chronic obstructive pulmonary disease, or recurrent or current respiratory infections; splenectomy; or recurrent or current gastrointestinal infections.
• Evidence of active or latent tuberculosis.
• Known or suspected hypersensitivity to the IP, to any excipients of the IP, humanized monoclonal antibodies, or Fc fusion protein therapeutics.
• History, or current diagnosis, of substance use disorder.
• Any abnormal clinical laboratory values deemed clinically significant by the Investigator and / or study Medical Monitor.
• Positive serology test result for human immunodeficiency virus antibody, hepatitis virus B surface antigen or hepatitis virus C antibody at Screening.
• Donation or loss of ≥ 480 mL of whole blood within 2 months or donation of plasma within 14 days before Day -1.
• Plans to participate in another investigational drug study while enrolled in this study, or has participated in any other investigational drug study in which they were known to have been administered a monoclonal antibody or biological IP within 4 months, any other investigational drug study within 60 days or > 3 investigational drug studies within 12 months before IP administration.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Program Director

Role: STUDY_DIRECTOR

CSL Behring

Locations

PRA Health Sciences

Groningen, , Netherlands

Hammersmith Medicines Research

London, , United Kingdom

Countries

Netherlands; United Kingdom

Other Identifiers

2017-003478-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSL730_1001

Identifier Type: -

Identifier Source: org_study_id