NCT07005284进行中（未招募）1 期
A Single-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3981314 in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to investigate the safety of LY3981314 when administered subcutaneously (SC) (under the skin), and how it's processed in the body.
The study will last approximately 25 weeks, excluding a screening period with an optional extension to approximately 49 weeks for qualifying participants.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiogram (ECG)
- •Individuals assigned male at birth who agree to follow contraceptive requirements, or individuals assigned female at birth and not of childbearing potential
- •Have venous access sufficient to allow for blood sampling
- •Have a body weight within 45 to 145 kilograms (kg) and body mass index within the range of 18.5 to 35 kilogram per square meter (kg/m²) (inclusive)
- •For Part B:
- •Japanese participants must be first-generation Japanese, defined as the participant, the participant's biological parents, and all of the participant's biological grandparents being of exclusive Japanese descent and born in Japan
- •To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
排除标准
- •Have known allergies to LY3981314, related compounds, or any components of the formulation
- •Have a significant history of or current rheumatologic, cardiovascular, respiratory, renal, gastrointestinal, endocrine (such as Cushing syndrome, hyperaldosteronism), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data
- •Have received at least 1 live vaccine within 28 days of screening, or intend to do so during the study, or within 28 days after the study
- •Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening, or intend to do so during the study, or within 28 days after the study
- •Show evidence of active or latent tuberculosis (TB)
- •Have used, or intend to use, prescription or nonprescription medication within 14 days prior to dosing (or 5 half-lives - whichever is longer)
- •Have a diagnosis or history of malignant disease
- •Have a history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection that, in the opinion of the sponsor or investigator, poses an unacceptable risk to the participant
- •Have had any significant infections within 3 months prior to the screening visit or develop any of these infections before the randomization visit
- •Have used, or intend to use, prescription or nonprescription medication within 14 days prior to dosing (or 5 half-lives - whichever is longer)
- •Have participated in a clinical study involving an investigational product within the last 30 days of the final drug administration (or 5 half-lives, whichever is longer)
- •Have donated 500 milliliters (mL) of blood or more or participated in a clinical study that required a blood volume of at least 500 mL, within the past 3 months
研究组 & 干预措施
Placebo Part B
Placebo Comparator
Placebo administered SC
干预措施: Placebo (Drug)
LY3981314 Part A
Experimental
Single-ascending doses of LY3981314 administered subcutaneously (SC)
干预措施: LY3981314 (Drug)
LY3981314 Part B
Experimental
Single dose of LY3981314 administered SC
干预措施: LY3981314 (Drug)
Placebo Part A
Placebo Comparator
Placebo administered SC
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Approximately Week 25
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3981314(Baseline Up to Approximately Week 25)
- PK: Maximum Concentration (Cmax) of LY3981314(Baseline up to Approximately Week 25)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A study in healthy volunteers to evaluate the effect of repeated LPS skin challenges in a single individualChallenge model developmentChallengeNL-OMON55995Hoffmann-La Roche8
进行中（未招募）
Unknown
A study in healthy volunteers to evaluate the effect of lipopolysaccharide in the skin in a single individualRepeated lipopolysaccharide skin challengesSkin and Connective Tissue DiseasesISRCTN13536369F. Hoffmann-La Roche Ltd8
已完成
1 期
A randomized, placebo controlled, double blind, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single escalating doses of SAN-300 when administered to healthy subjects and patients with rheumatoid arthritisActive Rheumatoid ArthritisInflammatory and Immune System - Rheumatoid arthritisACTRN12611000123943Santarus, Inc.74
已完成
3 期
An exploration of the antioxidant, immunomodulatory, and anti-inflammatory activities of Ambrotose in healthy individuals.Immune system function in healthy individualsAntioxidant levels in healthy individualsInflammatory and Immune System - Normal development and function of the immune systemAlternative and Complementary Medicine - Herbal remediesACTRN12608000078358Mannatech, Inc60
已完成
1 期
Safety study of an improved aluminium-free Hepatitis B vaccine based on a natural plant sugarHepatitis B preventionInfection - Other infectious diseasesPublic Health - EpidemiologyACTRN12607000598482Vaxine Pty Ltd24