A Study of LY3316531 in Healthy Participants

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: LY3316531

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 to 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

16 participants in 3 patient groups, including a placebo group

LY3316531 Dose 1
Experimental group
Description:
LY3316531 administered IV
Treatment:
Drug: LY3316531
LY3316531 Dose 2
Experimental group
Description:
LY3316531 administered IV
Treatment:
Drug: LY3316531
Placebo
Placebo Comparator group
Description:
Placebo administered IV
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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