NCT07093580招募中1 期
Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants
Shionogi2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年7月29日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m^2)
排除标准
- •Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (for example, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.
- •History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- •Require medication or other treatment (for example, dietary restrictions or physical therapy).
- •Participated in any other clinical study involving an investigational study intervention or any other type of medical research within 30 days, or 5 times the half-life of the investigational drug, before signing of the informed consent form (ICF) for this study or who are currently participating in such a study.
- •Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen/antibody.
- •Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test result, positive transcription-mediated amplification test result, positive antigen test result, or any other test approved according to local regulations at check in for each period on admission.
- •Known allergy/sensitivity or any hypersensitivity to components of S-892216-LAI or placebo for S-892216-LAI.
- •Used cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part 1 (Single Ascending Dose)
Experimental
Participants will receive a single dose of S-892216-LAI or placebo on Day 1.
干预措施: S-892216-LAI (Drug)
Part 1 (Single Ascending Dose)
Experimental
Participants will receive a single dose of S-892216-LAI or placebo on Day 1.
干预措施: Placebo (Drug)
Part 2 (Multiple Ascending Dose)
Experimental
Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively.
干预措施: S-892216-LAI (Drug)
Part 2 (Multiple Ascending Dose)
Experimental
Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively.
干预措施: Placebo (Drug)
结局指标
主要结局
Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Day 1 through Day 364
Part 2: Number of Participants With TEAEs
时间窗: Day 1 through Day 448
次要结局
- Part 2: Tmax of S-892216 and its Metabolites(Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2)
- Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites(Day 1 (pre-administration, up to 12 hours post-administration) through Day 364)
- Part 2: Cmax of S-892216 and its Metabolites(Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2)
- Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites(Day 1 (pre-administration, up to 12 hours post-administration) through Day 364)
- Part 2: AUC0-last of S-892216 and its Metabolites(Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2)
- Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216 and its Metabolites(Day 1 (pre-administration, up to 12 hours post-administration) through Day 364)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.TumorNCT05203601Shanghai Institute Of Biological Products36
已完成
1 期
A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular DegenerationAge-Related Macular DegenerationNCT02022501Santen Inc.10
Unknown
1 期
A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML)Acute Myeloid LeukemiaNCT04827069Sunshine Lake Pharma Co., Ltd.80
已完成
1 期
S 81694 Plus Paclitaxel in Metastatic Breast CancerMetastatic Triple Negative Breast CancerMetastatic Breast CancerNCT03411161Institut de Recherches Internationales Servier22
招募中
1 期
Safety, Tolerability, and Pharmacokinetics of HL-003 in Healthy SubjectsNCT06867393Shanghai Kechow Pharma, Inc.52