A Study of LY3316531 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3316531; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03611608

2018-000710-38 (EudraCT Number)

16667

I9H-MC-FFAB (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess study drug activity by giving LY3316531 or placebo into a vein in the arm and then measuring blood flow of the skin, after capsaicin is applied to skin's surface. The study will last about 16 weeks inclusive of the screening period.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be healthy males
• Must be abstinent or use condoms with spermicide as well as 1 additional highly effective method of contraception or effective method of contraception during the study and for 5 months following dosing of study drug
• Must have a body mass index between 18 to 32.0 kilogram per meter square (kg/m²), inclusive, and a minimum body weight of 50 kilogram (kg)
• Must have suitable skin characteristics for the dermal capsaicin challenge and have demonstrated at least a 100 percent (%) increase in dermal flow following capsaicin challenge as part of the screening procedures and measured through laser Doppler imaging (LDI)

Exclusion criteria

• Must not have evidence of clinically significant active infection, fever of 100.5 degrees Fahrenheit (°F) (38 degrees Centigrade (°C)) or above, at baseline
• Must not show evidence of active or latent tuberculosis (TB)
• Must not have received live, attenuated live, or non-live vaccine(s) within 28 days of screening or intend to receive during the study
• Must not be immunocompromised
• Must not have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
• Must not have significant allergies to humanised monoclonal antibodies
• Have a history of multiple or severe allergies or has had an anaphylactic reaction to prescription or nonprescription drugs or food
• Must not have had any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin
• Must not have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin that may interfere with the study assessments
• Must avoid excess tanning throughout the study and cannot cover forearms for 24 hours prior to each treatment period
• Must not have excessive hair growth on the volar surface of the forearm or currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis that cannot be discontinued for the duration of the study; participant must not have used any topical treatments within 7 days of the start of the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 3 patient groups, including a placebo group

300 mg LY3316531 Dose 1

Experimental group

Description:

LY3316531 administered IV

Treatment:

Drug: LY3316531

LY3316531 Dose 2

Experimental group

Description:

The optional additional cohort (Dose 2) was not implemented as the data desired for treatment effect on dermal blood flow (DBF) was generated at the initial Dose 1 (300mg LY3316531) LY3316531 administered IV

Treatment:

Drug: LY3316531

Placebo

Placebo Comparator group

Description:

Placebo administered IV

Treatment:

Drug: Placebo