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Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics of WD-890 tablets in Chinese healthy subjects

Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics of WD-890 tablets in Chinese healthy subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100460
Enrollment
Unknown
Registered
2025-04-09
Start date
2023-11-25
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Interventions

Single dose increasing group:Single oral administration of WD890 tablets
Multiple dose escalation group:Multiple oral administration of WD890 tablets
FE group:Single oral administration of WD890 tablets on an empty stomach or after a meal

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (only selected if all inclusion criteria are met) 1. Healthy adult subjects (including borderline values) aged 18 to 50 years of age, both male and female; 2. Male subjects should not weigh less than 50 kg and female subjects should not weigh less than 45 kg. BMI (=Weigh (kg)/Height2) in the range of 19 to 26 kg/m2 (including borderline values); 3. The subjects have no history of chronic or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, psychiatric, neurological, gastrointestinal system, etc., and their overall health condition is good; 4. The subjects (male or female) agree to use contraception (using medically recognized effective contraceptive measures) from the screening period until 6 months after the last use of the investigational drug; And there is no plan to donate sperm/eggs during the trial period and within 6 months after the trial ends; 5. Participants need to be able to communicate well with researchers, understand and comply with the requirements of this study, have a full understanding of the trial content, process, and possible adverse reactions, and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria (excluded if any of the following conditions are met) 1. Allergic constitution (multiple drug and food allergies), with a history of severe allergies/hypersensitivity reactions/specific allergic diseases (such as asthma, urticaria, etc.), or those who may be allergic to the test drug or any component of the test drug according to the researcher's history of hypersensitivity reactions to drugs with chemical structures or categories similar to WD-890, or those who are allergic to other Janus tyrosine kinase (JAK) inhibitors (such as tofacitinib, baritinib, etc.); 2. Subjects with a history or present history of metabolic, liver, kidney, blood, lung, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disorders with abnormal clinical manifestations and/or deemed unsuitable by the researcher to participate in this study; 3. Any history of diseases that may alter drug absorption, distribution, metabolism, or excretion, including but not limited to the following: A. History of intestinal diseases such as inflammatory bowel disease, digestive ulcers, gastroesophageal reflux disease, excessive gastric acid secretion, gastrointestinal bleeding, and irritable bowel syndrome; B. History of habitual diarrhea or habitual constipation; C. Previous history of gastrointestinal surgery, such as gastrectomy, gastrointestinal ostomy, or intestinal resection (excluding appendicitis surgery); D. History of pancreatic injury or pancreatitis; E. History of cholecystectomy; F. History of liver disease or liver injury; G. History of kidney disease or kidney injury, history of impaired kidney function, or history of urinary tract obstruction or difficulty urinating; 4. Subjects with increased risk of infection, including but not limited to the following situations: A. Those who have a history of tuberculosis or relevant symptoms or examination results (such as T-SPOT and imaging results) during screening, indicating active or concealed tuberculosis; B. Individuals who have had or are currently suffering from severe infections within the 30 days prior to the screening period, such as cellulitis, pneumonia, sepsis, etc., and require hospitalization and/or intravenous injection of antibiotics for treatment; C. A history of severe herpes zoster or severe herpes simplex infection, including but not limited to any disseminated herpes simplex, herpetic encephalitis, ocular herpes, or recurrent herpes zoster (recurrence defined as 2 episodes within 2 years); Or currently coexisting with individuals infected with herpes; D. Belonging to the high-risk group for HIV infection within 6 months; E. During screening, there may be active infections (such as viral infections, bacterial infections, fungal infections, parasitic infections, etc.), or acute infections/diseases or concomitant medication occurring from the screening stage to the time of taking the investigational drug; F. Select subjects who have received live or attenuated vaccines within 8 weeks prior to screening, or have received inactivated vaccines within 4 weeks; 5. Those who have the following conditions during the screening period or check-in: A. Abnormal vital signs and physical examination with clinical significance; Including systolic blood pressure139mmHg, diastolic blood pressure89mmHg, heart rate90 beats per minute; B. Any clinically significant rhythm, conduction, or morphological abnormalities in resting el

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters;Safety indicators;

Countries

China

Contacts

Public ContactYu Zhang

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

zhangwkp@163.com+86 139 7129 2838

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026