A Study of LY3361237 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3361237 - SC; Drug: LY3361237 - IV; Drug: Placebo - SC; Drug: Placebo - IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03695198

I9S-MC-BTAA (Other Identifier)

16969

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 4 patient groups, including a placebo group

LY3361237 - Subcutaneous (SC)

Experimental group

Description:

LY3361237 administered SC

Treatment:

Drug: LY3361237 - SC

Placebo - SC

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo - SC

LY3361237 - Intravenous (IV)

Experimental group

Description:

LY3361237 administered IV

Treatment:

Drug: LY3361237 - IV

Placebo - IV

Placebo Comparator group

Description:

Placebo administered IV

Treatment:

Drug: Placebo - IV