CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Donanemab +1 moredrug
Likely dose
Single intravenous dose of donanemab (specific dose not stated)AI-extracted
Key inclusion· 3
  • ✓Native Chinese participants (participant, biological parents, and all four biological grandparents of Chinese origin)
  • ✓Overtly healthy as determined by medical evaluation
  • ✓BMI between 18.0 and 28.0 kg/m²
Key exclusion· 7
  • ✕Known allergies to donanemab, related compounds, or formulation components, or history of significant atopy
  • ✕Prior biologic agents (monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives, whichever is longer
  • ✕History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid artery occlusion, stroke, or epilepsy
  • ✕Positive serology for HIV, hepatitis C antibody, or hepatitis B surface antigen

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05533411
NCT05533411Phase 1Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Sep 9, 2022·Updated Oct 4, 2024

In Brief

A Phase 1 clinical trial evaluating Donanemab and Placebo for Healthy. Completed, enrolled 36 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedSep 9, 2022
Enrollment StartSep 14, 2022
Primary CompletionJan 5, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.8 years ago

Interventions

Donanemabdrug

Administered IV.

Placebodrug

Administered IV.