- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03148431
A Study of LY3002815 in Healthy Participants
A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3002815 in Healthy Subjects
The purposes of this study are to determine:
- The safety of the study drug and any side effects that might be associated with it.
- How much of the study drug gets into the blood stream and how long it takes the body to remove it in healthy participants.
Participants will be admitted to the Clinical Research Unit (CRU) for 3 overnight stays.
This study involves a single dose of LY3002815 or placebo given as an injection into the vein. This study will last approximately 16 weeks including screening. Additional follow-up may be required.
This study is for research purposes only, and is not intended to treat any medical condition.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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UK
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Leeds, UK, Det Forenede Kongerige
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Are overtly healthy males or females, as determined by medical history and physical examination. Males will be required to use reliable method of birth control. Females have to be of non-child-bearing potential
- Have a body mass index (BMI) of 18 to 32 kilograms per meter squared (kg/m²) inclusive, at screening
Exclusion Criteria:
- Have family history of early onset Alzheimer's Disease (AD)
- Have impaired cognitive function
- Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
- Have significant allergic reactions to LY3002815, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
- Women who are lactating
- Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: LY3002815
Escalating doses of LY3002815 administered intravenously (IV) once in healthy participants
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Administered IV
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Placebo komparator: Placebo
Placebo administered IV once in healthy participants
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Administreret IV
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Tidsramme: Baseline through at least 85 days after administration of study drug
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Baseline through at least 85 days after administration of study drug
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3002815
Tidsramme: Baseline through at least 85 days after administration of study drug
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Baseline through at least 85 days after administration of study drug
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Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3002815
Tidsramme: Baseline through at least 85 days after administration of study drug
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Baseline through at least 85 days after administration of study drug
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 16529
- I9G-MC-CCBA (Anden identifikator: Eli Lilly and Company)
- 2016-004453-33 (EudraCT nummer)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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