Overview
A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
Status:
Completed
Completed
Trial end date:
2024-02-20
2024-02-20
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Jacobio Pharmaceuticals Co., Ltd.Treatments:
Calcium
Digoxin
Itraconazole
Midazolam
Omeprazole
Rifampin
Rosuvastatin Calcium
Criteria
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