A Study of LY3316531 in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2019-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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300 mg LY3316531 Dose 1

LY3316531 administered IV

Group Type EXPERIMENTAL

LY3316531

Intervention Type DRUG

Administered IV

LY3316531 Dose 2

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

Group Type EXPERIMENTAL

LY3316531

Intervention Type DRUG

Administered IV

Placebo

Placebo administered IV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV

Interventions

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LY3316531

Administered IV

Intervention Type DRUG

Placebo

Administered IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes