A Phase 1 Randomized, Placebo-Controlled Study to Determine the Effect of LY3316531 on Capsaicin-Induced Dermal Blood Flow in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change From Baseline in Capsaicin-Induced Dermal Blood Flow Following LY3316531 Compared to Placebo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
300 mg LY3316531 Dose 1
LY3316531 administered IV
干预措施: LY3316531 (Drug)
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
干预措施: LY3316531 (Drug)
Placebo
Placebo administered IV
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Capsaicin-Induced Dermal Blood Flow Following LY3316531 Compared to Placebo
时间窗: Baseline, Day 24
To assess target neutralization of calcitonin gene-related peptide by LY3316531 versus placebo, the capsaicin-induced dermal blood flow was measured at baseline (before administration of LY3316531 or placebo) as well as 24 days after a single intravenous dose of LY3316531 or placebo
次要结局
- Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531(Pre-dose, end of infusion (30min), and 2 hours (h), 6h, 24h, 10 days, 24 days, 38 days, 52 days, 66 days and 80 days post-dose)
- Pharmacokinetics: Area Under Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3316531(Pre-dose, end of infusion (30min), and 2 hours (h), 6h, 24h, 10 days, 24 days, 38 days, 52 days, 66 days and 80 days post-dose)