Donanemab
DrugAdministered IV.
Other names: LY3002813
NCT Number: NCT05533411
The main purpose of this study is to evaluate the safety and tolerability of donanemab (LY3002813) when administered as single dose in healthy Chinese participants. The study will also assess how fast donanemab gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 85 days.
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Notify Me18 year–40 year
All sexes
Interventional
Phase 1
Peking University First Hospital, Beijing, Beijing 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: LY3002813
Administered IV.
Time frame: Baseline up to Day 85
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.
Time frame: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose
PK: Cmax of Donanemab
Time frame: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose
PK: AUC[0-∞] of Donanemab
Eli Lilly and Company
Industry
A Parallel-group Treatment, Phase 1, Participant- and Investigator-Blind, Randomized Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Dose of Donanemab Compared With Placebo in Healthy Chinese 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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