Clinical trial NCT03375606: Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2017-12-18
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: Percentage of subjects with adverse events overall, and by causality and severity
timeFrame: Up to 8 weeks after infusion
Secondary outcomes:
measure: Maximum observed concentration (Cmax) of CSL730 in serum
timeFrame: Before study drug infusion and up to 56 days after the start of the infusion.
measure: Area under the concentration-time curve from time 0 to the last collection time (AUC0-last) of CSL730 in serum
timeFrame: Before study drug infusion and up to 56 days after the start of the infusion.
measure: Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL730 in serum
timeFrame: Before study drug infusion and up to 56 days after the start of the infusion.
measure: Time of maximum observed concentration (Tmax) of CSL730 in serum
timeFrame: Before study drug infusion and up to 56 days after the start of the infusion.
measure: Terminal elimination half-life (T1/2) of CSL730 in serum
timeFrame: Before study drug infusion and up to 56 days after the start of the infusion.
measure: Total systemic clearance (CL) of CSL730 in serum
timeFrame: Before study drug infusion and up to 56 days after the start of the infusion.
measure: Volume of distribution during the elimination phase (Vz) of CSL730 in serum
timeFrame: Before study drug infusion and up to 56 days after the start of the infusion.
measure: Number of subjects with anti-CSL730 antibodies in serum
timeFrame: Before study drug infusion and up to 56 days after the start of the infusion.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
affiliation: CSL Behring
name: Program Director
role: STUDY_DIRECTOR
References: