A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 7/25/2018 |
| Start Date: | April 25, 2016 |
| End Date: | July 10, 2018 |
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
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 42 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.
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 42 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.
Inclusion Criteria:
- Overtly healthy males or females of non-childbearing potential and who have given
consent and are reliable and willing to make themselves available for the duration of
the study and are willing to follow study procedures
- AD participants must be at least 50 years of age and have diagnostic criteria
consistent with either mild cognitive impairment due to AD or mild-to moderate AD and
have a positive florbetapir positron emission tomography (PET) scan
Exclusion Criteria:
- Have known allergies to LY3303560, related compounds or any components of the
formulation, or history of significant atopy
- Have an increased risk of seizures
- For AD participants, evidence of macrohemorrhage or greater than 4 microhemorrhage by
magnetic resonance imaging (MRI)
We found this trial at
2
sites
Baltimore, Maryland 21225
Principal Investigator: Azra Hussaini
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Glendale, California 91206
Principal Investigator: Hakop Gevorkyan
Phone: 818-254-1624
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