A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects

Allist Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: JAB-21822; Drug: Itraconazole; Drug: Omeprazole; Drug: Midazolam , Rosuvastatin calcium and digoxin; Drug: Rifampicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06162169

JAB-21822-1010

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 4 patient groups

JAB-21822+Itraconazole

Experimental group

Treatment:

Drug: Itraconazole

Drug: JAB-21822

JAB-21822+ Rifampicin

Experimental group

Treatment:

Drug: Rifampicin

Drug: JAB-21822

JAB-21822+ Omeprazole

Experimental group

Treatment:

Drug: Omeprazole

Drug: JAB-21822

Dazolam , Rosuvastatin calcium and digoxin with JAB-21822

Experimental group

Treatment:

Drug: Midazolam , Rosuvastatin calcium and digoxin

Drug: JAB-21822