Mirikizumab - IV
DrugAdministered IV
Other names: LY3074828
NCT Number: NCT04137380
The main purpose of this study is to evaluate the safety of the study drug known as mirikizumab. The study will investigate how the body processes the study drug. It will last up to about 4 months for each participant.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Shanghai Xuhui Central Hospital, Xuhui District, Shanghai Municipality, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered IV
Other names: LY3074828
Administered SC
Other names: LY3074828
Administered IV
Administered SC
Time frame: Baseline through Day 85
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of serious adverse events (SAEs) and other non-serious adverse events (NSAEs), regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Time frame: 0 min, 0.25 hours (h), 0.5 h, 1 h, 2 h and 4 h post first injection
The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (>30 and ≤70), and severe pain (>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).
Time frame: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose
PK: Cmax of Mirikizumab was evaluated.
Time frame: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose
PK: AUC(0-∞) of Mirikizumab was evaluated.
Time frame: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose
PK: AUC(0-tlast) of Mirikizumab was evaluated.
Eli Lilly and Company
Industry
A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Healthy Chinese Subjects
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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