A Study of LY3361237 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3361237 - SC; Drug: Placebo - SC; Drug: LY3361237 - IV; Drug: Placebo - IV

• Registration Number: NCT03695198
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Study Start: 2018-10-26
• Primary Completion: 2019-08-29
• Study Completion: 2019-08-29
• Status Verified: 2019-09-01
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3361237 - Subcutaneous (SC)	LY3361237 - SC	LY3361237 administered SC
Placebo - SC	Placebo - SC	Placebo administered SC
LY3361237 - Intravenous (IV)	LY3361237 - IV	LY3361237 administered IV
Placebo - IV	Placebo - IV	Placebo administered IV

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

California Clinical Trials Medical Group; 🇺🇸 Glendale, California, United States