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

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ClinicalTrials.gov Identifier: NCT03375606
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 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
Estimated Primary Completion Date : September 22, 2019
Estimated Study Completion Date : September 22, 2019

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




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. ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375606


Contacts
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Contact: Trial Registration Coordinator +1 610 878 4000 clinicaltrials@cslbehring.com

Locations
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Netherlands
PRA Health Sciences Recruiting
Groningen, Netherlands
United Kingdom
Hammersmith Medicines Research Recruiting
London, United Kingdom
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Program Director CSL Behring

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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03375606     History of Changes
Other Study ID Numbers: CSL730_1001
2017‐003478‐15 ( EudraCT Number )
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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