The purpose of this study is to evaluate the effectiveness, safety and tolerability of zilucoplan auto-injector (ZLP-AI) self-administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Zilucoplan will be self-administered subcutaneously by study participants at pre-specified time points.
Dv0013 50628
New Haven, Connecticut, United States
Dv0013 50634
Tampa, Florida, United States
Dv0013 50648
Columbia, Missouri, United States
Dv0013 50556
Chapel Hill, North Carolina, United States
Percentage of effective self-administrations of zilucoplan using the zilucoplan-auto-injector (ZLP-AI) from Visit 1 to Visit 8
Effective self-administration is defined as: Complete dose delivery: completeness of the delivery as confirmed by the Investigator. The entire dose of investigational medicinal product (IMP) should be completely delivered (that is, the yellow plunger that can be seen through the device window should be completely depressed).
Time frame: Visit 1 (Day 1) to Visit 8 (Day 14)
Percentage of effective self administrations of zilucoplan using ZLP-AI at Visit 8
Effective self-administration is defined as: Complete dose delivery: completeness of the delivery as confirmed by the Investigator. The entire dose of IMP should be completely delivered (that is, the yellow plunger that can be seen through the device window should be completely depressed).
Time frame: Visit 8 (Day 14)
Percentage of effective self administration of zilucoplan using ZLP-AI at Visit 1
Effective self-administration is defined as: Complete dose delivery: completeness of the delivery as confirmed by the Investigator. The entire dose of IMP should be completely delivered (that is, the yellow plunger that can be seen through the device window should be completely depressed).
Time frame: Visit 1 (Day 1)
Occurrence of serious adverse events (SAEs) during the course of the study
A SAE is defined as any untoward medical occurrence that, at any dose: a. Results in death; b. Is life-threatening; c. Requires inpatient hospitalization or prolongation of existing hospitalization; d. Results in persistent disability/incapacity; e. Is a congenital anomaly/birth defect; f. Important medical events.
Time frame: From Visit 1 (Day 1) up to the Safety Follow-up Visit (up to Day 21)
Occurrence of treatment-emergent adverse events (TEAEs) during the course of the study
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Dv0013 50635
Columbus, Ohio, United States
Dv0013 50555
Austin, Texas, United States
Dv0013 50636
Greenfield, Wisconsin, United States
Dv0013 40609
Katowice, Poland
Dv0013 40759
Krakow, Poland
Dv0013 40605
Poznan, Poland
...and 1 more locations
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time frame: From Visit 1 (Day 1) up to the Safety Follow-up Visit (up to Day 21)
Occurrence of nonserious adverse device effects (ADE) during the course of the study
An ADE is defined as an adverse event related to the use of an investigational medical device. This definition includes any adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device as well as any event resulting from use error or from intentional misuse of the investigational medical device.
Time frame: From Visit 1 (Day 1) up to the Safety Follow-up Visit (up to Day 21)
Occurrence of serious adverse device effects (SADE) during the course of the study
A SADE is defined as an adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. A SAE is defined as any untoward medical occurrence that, at any dose: a. Results in death; b. Is life-threatening; c. Requires inpatient hospitalization or prolongation of existing hospitalization; d. Results in persistent disability/incapacity; e. Is a congenital anomaly/birth defect; f. Important medical events.
Time frame: From Visit 1 (Day 1) up to the Safety Follow-up Visit (up to Day 21)