NCT03375606

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_1 healthy

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2020

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

December 13, 2017

Last Update Submit

June 2, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects with adverse events overall, and by causality and severity

    Up to 8 weeks after infusion

Secondary Outcomes (8)

  • 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.

  • +3 more secondary outcomes

Study Arms (2)

CSL730

EXPERIMENTAL
Biological: CSL730

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

CSL730BIOLOGICAL

Solution for IV infusion

Also known as: Recombinant trivalent human IgG1 Fc multimer
CSL730
PlaceboOTHER

Saline solution for IV infusion

Placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males or females (postmenopausal or surgically sterile only) aged ≥ 20 to ≤ 55 years and of Caucasian or Japanese descent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PRA Health Sciences

Groningen, Netherlands

Location

Hammersmith Medicines Research

London, United Kingdom

Location

Study Officials

  • Program Director

    CSL Behring

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 18, 2017

Study Start

January 10, 2018

Primary Completion

June 22, 2020

Study Completion

June 22, 2020

Last Updated

June 3, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)GB(1)