DV0012 1
Groningen, Netherlands
NCT Number: NCT06511076
The purpose of this study is to assess the bioequivalence pharmacokinetics, safety, tolerability and device deficiencies of zilucoplan (ZLP) in healthy adult participants
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Groningen, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single sc injection of zilucoplan in the pre-specified sequence.
Other names: RA101495
Time frame: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
AUC was defined as the area under the plasma concentration-time curve from time zero (predose [Day 1]) to infinity for zilucoplan.
Time frame: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
AUC(0-t) was defined as the area under the plasma concentration-time curve from time 0 (predose [Day 1]) to the time of the last quantifiable concentration for zilucoplan.
Time frame: Baseline (Day 1 of each treatment period at predose) and at predefined time points up to 816 hours (Day 35) postdose
Cmax was defined as the maximum observed plasma concentration for zilucoplan.
Time frame: From Day 1 to EOS visit or ET visit (up to 82 days)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product, whether or not considered related to the investigational medicinal product. A TEAE was defined as any AE with a start date/time on or after the administration of IMP in each Treatment Period, and up to and including 40 days after the single dose in each Treatment Period (or up to the first dose in Period 2 (for TEAEs following the first dose in Period 1) or last contact date (for TEAEs following the first dose in Period 2) depending on which occurs first. Percentages were displayed to one decimal place and was correspond to whole participant counts due to rounding.
Time frame: From Day 1 to EOS visit or ET visit (up to 82 days)
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed:
Time frame: From Day 1 to EOS visit or ET visit (up to 82 days)
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed:
A SADE was defined as an adverse device effect that has resulted in any of the consequences characteristic of a SAE.
Time frame: From Day 1 to EOS visit or ET visit (up to 82 days)
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. An ADE was defined as an AE related to the use of an investigational medical device.
UCB Biopharma SRL
Industry
An Open-Label, Single Center, Randomized, 2-Way Crossover, Single-Dose, Bioequivalence Study of Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-Injector in Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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