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OpenTrials
Completed

NCT Number: NCT03695198

A Study of LY3361237 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3361237 - SC

Drug

LY3361237 administered SC

LY3361237 - IV

Drug

LY3361237 administered IV

Placebo - SC

Drug

Placebo administered SC

Placebo - IV

Drug

Placebo administered IV

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

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2018
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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