Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a BTLA Agonist Antibody (Venanprubart) in Healthy Participants, Patients with Systemic Lupus Erythematosus, and Patients with Psoriasis: Results From Three Phase 1 Studies [0.03%]
贝利木单抗在健康志愿者及系统性红斑狼疮和银屑病患者中的安全性、耐受性、药代动力学和免疫原性：三项1期研究结果
Andrew C Vendel,Olivier Benichou,Ching-Yun Chang et al.
Andrew C Vendel et al.
Venanprubart (LY3361237), an agonist antibody to B and T lymphocyte attenuator (BTLA), was developed as a potential treatment for autoimmune disorders, including systemic lupus erythematosus (SLE) and psoriasis. We tested venanprubart in th...
A Phase 1 Dose-Escalation, Food Effect, and Drug-Drug Interaction Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the MALT1 Inhibitor, SGR-1505, in Healthy Volunteers [0.03%]
一项I期剂量递增、饮食影响和药物相互作用研究，评估MALT1抑制剂SGR-1505在健康志愿者中的安全性和耐受性、药代动力学和药效学特征
Vipul K Gupta,Brian Yoo,Daniel Weiss et al.
Vipul K Gupta et al.
SGR-1505 is a novel small-molecule inhibitor of MALT1, a key mediator of NF-κB signaling implicated in the pathogenesis of B-cell malignancies. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of SGR-15...
A Thorough QT Study to Assess the Effects of Milvexian on Cardiac Repolarization in Healthy Participants [0.03%]
一项 thorough QT 研究，评估 milvexian 在健康受试者中对心脏复极化的影响
Peter Zannikos,JongHanne Park,Anna Dari et al.
Peter Zannikos et al.
Milvexian is an oral factor XIa inhibitor in development for prevention of major thromboembolic conditions. This randomized, double-blind, placebo- and positive-controlled, multiple-dose, four-period crossover study assessed the cardic safe...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jan;15(1):e70015. DOI:10.1002/cpdd.70015 2026
Evaluation of a New Formulation That Improves the Bioavailability and Food Effect of Abiraterone: An Open-Label, Crossover, Randomized, Controlled, Phase I Clinical Trial [0.03%]
评估改善阿比特龙生物利用度和食物效应的新剂型：一项开放标签、交叉、随机对照的I期临床试验
Mulin Yi,Shiqi Tu,Zeneng Cheng et al.
Mulin Yi et al.
This first-in-human phase I trial evaluated RL001, a self-emulsifying soft-capsule abiraterone developed to overcome the low bioavailability and food sensitivity associated with the 1000-mg Zytiga tablet that is used with prednisone accordi...
From Reflection to Acceleration: Clinical Pharmacology's 2025 Lessons and 2026 Opportunities [0.03%]
从反思到加速：临床药理学的2025年教训和2026年机遇
Amalia M Issa
Amalia M Issa
LP-001, a Novel Long-Acting EPO-Fc Fusion Protein: A Phase I Dose-Escalation Study of Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects [0.03%]
新型长效EPO-Fc融合蛋白LP-001：健康受试者I期剂量递增药代动力学、安全性和耐受性研究
Jie Yang,Jiaxiang Ding,Yuanyuan Xu et al.
Jie Yang et al.
The objective of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of LP-001 injection in healthy Chinese subjects. This was a single-center, double-blind, randomized, dose-escalation study. Fifty-six healthy adul...
Pharmacokinetic Interaction Between Atorvastatin and Hybutimibe in Healthy Chinese Volunteers [0.03%]
阿托伐他汀与海博麦布在健康受试者中的药代动力学相互作用研究
Jia-Ying Wang,Wen-Jun Chen,Zou-Rong Ruan et al.
Jia-Ying Wang et al.
Stains and cholesterol absorption inhibitors are frequently co-administered in the management of dyslipidemia. This study evaluated the pharmacokinetic (PK) interaction between atorvastatin and hybutimibe in healthy Chinese subjects. A rand...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jan;15(1):e70017. DOI:10.1002/cpdd.70017 2026
Assessment of the Intestinal CYP3A Contribution to Drug Interactions with Extended-Release Tacrolimus (LCPT) Using Grapefruit Juice [0.03%]
采用葡萄汁评价结肠CYP3A在长循环型他克莫司（LCPT）药物相互作用中的作用贡献率
Adekunle Alabi,Janice S Kerr,Mita Shah et al.
Adekunle Alabi et al.
Grapefruit juice (GFJ) is a known inhibitor of intestinal cytochrome P450 3A (CYP3A) metabolism leading to increased exposure to CYP3A substrates such as tacrolimus. The extended-release tacrolimus formulation Envarsus (LCPT) exhibits prolo...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jan;15(1):e70016. DOI:10.1002/cpdd.70016 2026
Impact of Sampling Window Variability on Pharmacokinetic Parameters Estimated by Non-Compartmental Analysis: Case Studies of Various Types of Drugs [0.03%]
取样间隔变化对非 compartment 分析估算药动学参数的影响：不同类型药物实例分析
Kyosuke Takahashi,Kazuhiko Asari,Kazuhiko Hanada
Kyosuke Takahashi
Non-compartmental analysis (NCA) is commonly used to estimate pharmacokinetic (PK) parameters in individual participants during Phase 1 studies. PK sampling schedules are important for accurately characterizing a drug's PK profile. However,...
Pharmacokinetics and Safety of Single-Dose Apraglutide in Individuals with Normal and Impaired Hepatic Function: A Phase 1, Open-Label Trial [0.03%]
单剂量Apraglutide在肝功能正常和轻至中度受损受试者中的药代动力学和安全性：一项I期、开放标记试验
Gerard Greig,Justin Hay,Patricia Valencia et al.
Gerard Greig et al.
Intestinal failure-associated liver disease occurs in 20% to 30% of patients with short bowel syndrome and intestinal failure (SBS-IF). Apraglutide is a glucagon-like peptide-2 (GLP-2) analog in clinical development for the treatment of pat...