Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2018-10-26
2019-08-29
Brief Summary
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* The safety of LY3361237 and any side effects that might be associated with it.
* How much LY3361237 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 4 overnight stays. The study will last about 12 weeks for each participant, not including screening.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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LY3361237 - Subcutaneous (SC)
LY3361237 administered SC
LY3361237 - SC
LY3361237 administered SC
Placebo - SC
Placebo administered SC
Placebo - SC
Placebo administered SC
LY3361237 - Intravenous (IV)
LY3361237 administered IV
LY3361237 - IV
LY3361237 administered IV
Placebo - IV
Placebo administered IV
Placebo - IV
Placebo administered IV
Interventions
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LY3361237 - SC
LY3361237 administered SC
LY3361237 - IV
LY3361237 administered IV
Placebo - SC
Placebo administered SC
Placebo - IV
Placebo administered IV
Eligibility Criteria
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Inclusion Criteria
* To qualify as Japanese for this study, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
* Between 18 (20 for Japanese participants) and 65 years of age.
* Have a body mass index of 18.0 to 32.0 kilograms per meter squared, inclusive, and a minimum body weight of 45.0 kilograms.
Exclusion Criteria
* Are immunocompromised
* Have evidence of chronic viral infection have received live vaccine(s) (including attenuated live vaccines) within 28 days of screening or intend to receive during the study (non-live or inactivated vaccinations are allowed). Bacillus Calmette-Guérin (BCG) vaccine must not have been administered within 12 months of screening
* Have had lymphoma, leukemia, or any malignancy or pre-malignant condition within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
18 Years
65 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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California Clinical Trials Medical Group
Glendale, California, United States
Countries
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Other Identifiers
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I9S-MC-BTAA
Identifier Type: OTHER
Identifier Source: secondary_id
16969
Identifier Type: -
Identifier Source: org_study_id
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