A Study of LY3361237 in Healthy Participants

NCT ID: NCT03695198

Last Updated: 2019-09-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-26

Study Completion Date

2019-08-29

Brief Summary

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The purposes of this study are to determine:

* 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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3361237 - Subcutaneous (SC)

LY3361237 administered SC

Group Type EXPERIMENTAL

LY3361237 - SC

Intervention Type DRUG

LY3361237 administered SC

Placebo - SC

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo - SC

Intervention Type DRUG

Placebo administered SC

LY3361237 - Intravenous (IV)

LY3361237 administered IV

Group Type EXPERIMENTAL

LY3361237 - IV

Intervention Type DRUG

LY3361237 administered IV

Placebo - IV

Placebo administered IV

Group Type PLACEBO_COMPARATOR

Placebo - IV

Intervention Type DRUG

Placebo administered IV

Interventions

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LY3361237 - SC

LY3361237 administered SC

Intervention Type DRUG

LY3361237 - IV

LY3361237 administered IV

Intervention Type DRUG

Placebo - SC

Placebo administered SC

Intervention Type DRUG

Placebo - IV

Placebo administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males or females, as determined by medical history and physical examination.
* 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

* Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-ray and TB testing
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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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