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

• ClinicalTrials.gov Identifier: NCT03375606
• Recruitment Status: Terminated
• First Posted: December 18, 2017
• Last Update Posted: June 3, 2021
• Sponsor: CSL Behring
• Information provided by (Responsible Party): CSL Behring

Study Description

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

Condition or disease	Intervention/treatment	Phase
Healthy	Biological: CSL730; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: January 10, 2018
• Actual Primary Completion Date: June 22, 2020
• Actual Study Completion Date: June 22, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: CSL730	Biological: CSL730; Solution for IV infusion; Other Name: Recombinant trivalent human IgG1 Fc multimer
Placebo Comparator: Placebo	Other: Placebo; Saline solution for IV infusion

Outcome Measures

Primary Outcome Measures :

1. Percentage of subjects with adverse events overall, and by causality and severity [ Time Frame: Up to 8 weeks after infusion ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Netherlands

PRA Health Sciences

Groningen, Netherlands

United Kingdom

Hammersmith Medicines Research

London, United Kingdom

Sponsors and Collaborators

CSL Behring

Investigators

• Study Director: Program Director; CSL Behring

More Information

• Responsible Party: CSL Behring
• ClinicalTrials.gov Identifier: NCT03375606
• Other Study ID Numbers: CSL730_1001; 2017-003478-15 ( EudraCT Number )
• First Posted: December 18, 2017
• Last Update Posted: June 3, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No