A Study of LY3361237 in Healthy Participants

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 26, 2018

Estimated Primary Completion Date

September 7, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration[ Time Frame: Baseline through Week 12 ]

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237[ Time Frame: Predose through Week 12 ]
PK: Cmax of LY3361237
PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237[ Time Frame: Predose through Week 12 ]
PK: AUC of LY3361237

Descriptive Information

Brief Title ^ICMJE

A Study of LY3361237 in Healthy Participants

Official Title ^ICMJE

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3361237 in Healthy Subjects

Brief Summary

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Basic Science

Condition ^ICMJE

Intervention ^ICMJE

Drug: LY3361237 - SC
LY3361237 administered SC
Drug: LY3361237 - IV
LY3361237 administered IV
Drug: Placebo - SC
Placebo administered SC
Drug: Placebo - IV
Placebo administered IV

Study Arms

Experimental: LY3361237 - Subcutaneous (SC)
LY3361237 administered SC
Placebo Comparator: Placebo - SC
Placebo administered SC
Experimental: LY3361237 - Intravenous (IV)
LY3361237 administered IV
Placebo Comparator: Placebo - IV
Placebo administered IV

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 7, 2019

Estimated Primary Completion Date

September 7, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: 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) Eli Lilly and Company

PRS Account

Verification Date

October 1, 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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