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A Study of LY3361237 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03695198
Collaborator
(none)
64
Enrollment
1
Location
4
Arms
10.1
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: LY3361237 - SC
  • Drug: LY3361237 - IV
  • Drug: Placebo - SC
  • Drug: Placebo - IV
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3361237 in Healthy Subjects
Actual Study Start Date :
Oct 26, 2018
Actual Primary Completion Date :
Aug 29, 2019
Actual Study Completion Date :
Aug 29, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3361237 - Subcutaneous (SC)

LY3361237 administered SC

Drug: LY3361237 - SC
LY3361237 administered SC
Placebo Comparator: Placebo - SC

Placebo administered SC

Drug: Placebo - SC
Placebo administered SC
Experimental: LY3361237 - Intravenous (IV)

LY3361237 administered IV

Drug: LY3361237 - IV
LY3361237 administered IV
Placebo Comparator: Placebo - IV

Placebo administered IV

Drug: Placebo - IV
Placebo administered IV

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237 [Predose through Week 12]

    PK: Cmax of LY3361237

  2. PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237 [Predose through Week 12]

    PK: AUC of LY3361237

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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-GuĂ©rin (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

Contacts and Locations

Locations

Site City State Country Postal Code
1 California Clinical Trials Medical Group Glendale California United States 91206

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT03695198
Other Study ID Numbers:
  • 16969
  • I9S-MC-BTAA
First Posted:
Oct 4, 2018
Last Update Posted:
Sep 4, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 4, 2019