NCT03695198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

October 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

October 2, 2018

Last Update Submit

September 2, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

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

    Baseline through Week 12

Secondary Outcomes (2)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237

    Predose through Week 12

  • PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237

    Predose through Week 12

Study Arms (4)

LY3361237 - Subcutaneous (SC)

EXPERIMENTAL

LY3361237 administered SC

Drug: LY3361237 - SC

Placebo - SC

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo - SC

LY3361237 - Intravenous (IV)

EXPERIMENTAL

LY3361237 administered IV

Drug: LY3361237 - IV

Placebo - IV

PLACEBO COMPARATOR

Placebo administered IV

Drug: Placebo - IV

Interventions

LY3361237 - SCDRUG

LY3361237 administered SC

LY3361237 - Subcutaneous (SC)
LY3361237 - IVDRUG

LY3361237 administered IV

LY3361237 - Intravenous (IV)
Placebo - SCDRUG

Placebo administered SC

Placebo - SC
Placebo - IVDRUG

Placebo administered IV

Placebo - IV

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Location

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 4, 2018

Study Start

October 26, 2018

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)