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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03375606
• Other study ID #: CSL730_1001
• Secondary ID: 2017-003478-15
• Status: Terminated
• Phase: Phase 1
• Start date: January 10, 2018
• Est. completion date: June 22, 2020

Study information

• Verified date: June 2021
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: June 22, 2020
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• CSL730
Solution for IV infusion

Other:
• Placebo
Saline solution for IV infusion

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with adverse events overall, and by causality and severity		Up to 8 weeks after infusion
Secondary	Maximum observed concentration (Cmax) of CSL730 in serum		Before study drug infusion and up to 56 days after the start of the infusion.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Total systemic clearance (CL) of CSL730 in serum		Before study drug infusion and up to 56 days after the start of the infusion.
Secondary	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.
Secondary	Number of subjects with anti-CSL730 antibodies in serum		Before study drug infusion and up to 56 days after the start of the infusion.