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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous CSL730 in Healthy Caucasian and Japanese Subjects

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

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Biological: CSL730; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • PRA Health Sciences
• United Kingdom
  • London, United Kingdom
    • Hammersmith Medicines Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Saline solution for IV infusion
Experimental: CSL730	Biological: CSL730; Solution for IV infusion; Other Names: Recombinant trivalent human IgG1 Fc multimer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with adverse events overall, and by causality and severity	Up to 8 weeks after infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Area under the concentration-time curve from time 0 to the last collection time (AUC0-last) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Time of maximum observed concentration (Tmax) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Terminal elimination half-life (T1/2) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Total systemic clearance (CL) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Volume of distribution during the elimination phase (Vz) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Number of subjects with anti-CSL730 antibodies in serum	Before study drug infusion and up to 56 days after the start of the infusion.

Collaborators and Investigators

• Sponsor: CSL Behring

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): June 22, 2020
• Study Completion (Actual): June 22, 2020

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CSL730_1001; 2017-003478-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No