Single-Dose, Dose-Escalation Study With LY3303560 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Subjects and Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease
Sponsor study identifier
Secondary identifiers
OTHER · Eli Lilly and Company
interventional
72
1 country
2
Study Start
April 25, 2016
Actual (reported)Primary Completion
July 10, 2018
Actual (reported)Study Completion
July 10, 2018
Actual (reported)The purpose of this study is to evaluate the safety and tolerability of the study drug, LY3303560. Side effects and laboratory results will be monitored. This study will involve single doses of LY3303560 administered intravenously (IV), meaning into a vein or subcutaneously (SC), meaning under the skin. Screening is required within 28 days before the start of the study for healthy participants and within 70 days before the start of the study for AD participants. The study requires about 16 weeks of each participant's time including a 4 day clinical research unit (CRU) admission and 10 follow-up appointments. This is the first time that this study drug is being given to participants. This study is for research purposes only, and is not intended to treat any medical condition.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 10, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 25, 2016
Actual (reported)April 26, 2016
Actual (reported)April 28, 2016
Actual (reported)July 10, 2018
Actual (reported)July 10, 2018
Actual (reported)September 21, 2023
Actual (reported)Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration
Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Baseline up to 146 days
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560
Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose
PK: Maximum Drug Concentration (Cmax) of LY3303560
Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose
Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 in Participants With Alzheimer's' Disease (AD)
Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose
Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 in Participants With Alzheimer's' Disease (AD)
Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose
Mean Change From Baseline in QT/QT Corrected (QTc) Interval
Baseline, 7 days postdose
Single IV infusion 7 milligram (mg), 21 mg, 70 mg, 210 mg, 700 mg, 1400 mg, 2800 mg, and 5600 mg of LY3303560 on Day 1 in healthy participants.
Single IV infusion of saline solution to match LY3303560 on Day 1 in healthy participants.
Single SC injection of 210 mg LY3303560 on Day 1 in healthy participants.
Administered IV
Administered IV
Parexel Early Phase Unit at Glendale
Glendale, California, 91206, United States
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, 21225, United States
Planned doses of 2800 mg and 5600 mg in AD participants were not implemented.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
72 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2016
First Posted
April 28, 2016
Study Start
April 25, 2016
Actual (reported)Administered SC
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 10, 2018
Actual (reported)Study Completion
July 10, 2018
Actual (reported)Last Updated
October 13, 2023
Results First Posted
September 21, 2023
Record last verified: 2023-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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