The Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Orally Dosed QY201, a Novel JAK1/TYK2 Inhibitor, in Chinese Healthy Subjects.
QY201 is a dual inhibitor targeting Janus Kinase 1/Tyrosine Kinase 2, developed for the treatment of atopic dermatitis and other autoimmune diseases. The pharmacokinetics (PK), pharmacodynamics (PD), tolerability, and safety of QY201 were assessed in a randomized, double‐blind study in healthy subje...
| Publicado en: | Journal of Clinical Pharmacology Vol. 65; no. 11; pp. 1474 - 1485 |
|---|---|
| Autores principales: | , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Wiley-Blackwell
Nov2025
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=188898487&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 188898487 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00912700 5WH jtl: Journal of Clinical Pharmacology issn: 00912700 maglogo: Y pubinfo: dt: Nov2025 vid: 65 iid: 11 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 188898487 185412935 188898487 188898487 10.1002/jcph.70053 188898487 ppf: 1474 ppct: 11 formats: tig: atl: The Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Orally Dosed QY201, a Novel JAK1/TYK2 Inhibitor, in Chinese Healthy Subjects. aug: au: Wang, Jia‐ying Gao, Ying‐hui Ruan, Zou‐rong Yang, Dan‐dan Li, Hua Qiao, Shi‐da Li, Jian‐hui You, Xin Shi, Jun Jiang, Bo affil: Center of Clinical Pharmacology, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou Zhejiang,, China sug: subj: Chinese Persons Dermatitis, Atopic Drug Therapy Autoimmune Diseases Drug Therapy Drug Combinations Janus Kinase Inhibitors Administration and Dosage Tyrosine Kinase Inhibitors Administration and Dosage Administration, Oral Janus Kinase Inhibitors Pharmacodynamics Janus Kinase Inhibitors Pharmacokinetics Tyrosine Kinase Inhibitors Pharmacodynamics Tyrosine Kinase Inhibitors Pharmacokinetics Drug Tolerance Evaluation Patient Safety Evaluation Human China Funding Source Male Female Adolescence Adult Middle Age Randomized Controlled Trials Random Assignment Double-Blind Studies Dose-Response Relationship, Drug ROC Curve C-Reactive Protein Drug Effects Neutrophils Drug Effects Tyrosine Kinase Inhibitors Adverse Effects Janus Kinase Inhibitors Adverse Effects Drug-Food Interactions Descriptive Statistics Data Analysis Software Confidence Intervals Adolescent: 13-18 years Adult: 19-44 years Middle Aged: 45-64 years Male Female ab: QY201 is a dual inhibitor targeting Janus Kinase 1/Tyrosine Kinase 2, developed for the treatment of atopic dermatitis and other autoimmune diseases. The pharmacokinetics (PK), pharmacodynamics (PD), tolerability, and safety of QY201 were assessed in a randomized, double‐blind study in healthy subjects. Population PK and PD models were developed to characterize the PK and PD of QY201. QY201 was absorbed and eliminated rapidly, and the exposure was approximately dose‐proportional over the 1‐40 mg dose range, with no significant accumulation after repeated dosing. A high‐fat meal reduced the maximum plasma concentration of QY201 by 40.7% but did not affect the area under the concentration‐time curve. The fraction of the QY201 dose eliminated in the urine unchanged was 22%. In the multiple ascending‐dose phase, the reduction of hypersensitive C‐reactive protein (hsCRP) and absolute neutrophil count (ANC) showed dose‐dependent trends within certain doses. The PK of QY201 was best described by a 2‐compartment model with first‐order absorption and elimination. The hsCRP was best described by an indirect response maximum drug effect (Emax) model. QY201 was generally safe and well tolerated following oral administration, with dose‐limiting toxicity of the highest tested dose of 40 mg being well tolerated. The favorable PK, PD, safety, and tolerability results from these studies supported evaluations of QY201 in future clinical trials. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|