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
54 participants
INTERVENTIONAL
2014-06-16
2017-02-11
Brief Summary
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Protocol amended in January, 2016 to include first generation Japanese participants.
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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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LY3041658 (IV)
Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts.
LY3041658 (IV)
Administered as slow IV infusion
LY3041658 (SC)
Single dose of LY3041658 administered subcutaneously (SC).
LY3041658 (SC)
Administered SC
Placebo
Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion.
Placebo
Administered as slow IV infusion
Interventions
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LY3041658 (SC)
Administered SC
LY3041658 (IV)
Administered as slow IV infusion
Placebo
Administered as slow IV infusion
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m²).
* Absolute neutrophil count at screening should be ≥1.8 and ≤7.2 x 10\^3/microliter (uL), inclusive.
* First-generation Japanese:
* Participant, biological parents, and biological grandparents must be of exclusive Japanese descent and born in Japan.
* Are 20 to 65 years of age, inclusive, at the time of initial screening.
Exclusion Criteria
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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Parexel Early Phase Unit at Glendale
Glendale, California, United States
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, United States
Countries
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Other Identifiers
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I7P-MC-DSAA
Identifier Type: OTHER
Identifier Source: secondary_id
15164
Identifier Type: -
Identifier Source: org_study_id
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