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A Study of LY3361237 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03695198
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Healthy Drug: LY3361237 - SC Drug: LY3361237 - IV Drug: Placebo - SC Drug: Placebo - IV Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 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 : October 26, 2018
Estimated Primary Completion Date : August 29, 2019
Estimated Study Completion Date : August 29, 2019

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




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 [ 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


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237 [ Time Frame: Predose through Week 12 ]
    PK: Cmax of LY3361237

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695198


Contacts
Contact: This is a single site clinical trial. -877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
United States, California
California Clinical Trials Medical Group Recruiting
Glendale, California, United States, 91206
Contact    818-254-1624      
Principal Investigator: Hakop Gevorkyan         
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03695198     History of Changes
Other Study ID Numbers: 16969
I9S-MC-BTAA ( Other Identifier: Eli Lilly and Company )
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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