A Single-center, Non-randomized, Open-lable, Self-controlled Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects

JAB-21822-1010

This is a phase I study to evaluate drug-drug interactions (DDIs) of JAB-21822 as a perpetrator combined with midazolam , rosuvastatin, and digoxin and to evaluate DDIs of JAB-21822 as a victim combined with itraconazole， rifampicin， and omeprazole in healthy subjects.

2023-11-25

2024-06-01

2024-07-01

Recruiting

Early phase I

66

Inclusion Criteria: 1. Male or female ；Healthy subjects aged 18 to 50 years (including both ends) at the time of signing informed consent 2. Male subjects weighed ≥50kg, female subjects weighed ≥45kg, body mass index (BMI) was between 19.0 and 26.0kg/m2, BMI= weight (kg)/height 2 (m2), including boundary values. 3. Subjects voluntarily signed written informed consent and were able to communicate well with the investigator Exclusion Criteria: 1. History of severe systemic diseases, history of liver and kidney insufficiency, history of mental illness, history of drug dependence; 2. Patients with a history of interstitial pneumonia, pulmonary fibrosis or other interstitial lung diseases who were not eligible for admission by the investigators; 3. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, and have digestive diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months before the first dose; 4. The investigator believes that the subject has any other circumstances that make him or her unfit to participate in this clinical trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}

2023-12-08