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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: JAB-21822; Drug: Midazolam , Rosuvastatin calcium and digoxin; Drug: Itraconazole; Drug: Rifampicin; Drug: Omeprazole

• Registration Number: NCT06162169
• Lead Sponsor: Allist Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-25
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-08
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-20
• Status Verified: 2024-06
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JAB-21822+Itraconazole	JAB-21822	-
Dazolam , Rosuvastatin calcium and digoxin with JAB-21822	Midazolam , Rosuvastatin calcium and digoxin	-
JAB-21822+Itraconazole	Itraconazole	-
JAB-21822+ Rifampicin	Rifampicin	-
JAB-21822+ Omeprazole	JAB-21822	-
JAB-21822+ Omeprazole	Omeprazole	-
JAB-21822+ Rifampicin	JAB-21822	-
Dazolam , Rosuvastatin calcium and digoxin with JAB-21822	JAB-21822	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822	approximately 10 days
Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822	approximately 10 days
Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin	approximately 10 days
Observed maximum concentrations (Cmax )of JAB-21822	approximately 10 days
Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin	approximately 10 days
Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin	approximately 10 days

Trial Locations

Locations (1)

Beijing GoBroad Hospital; 🇨🇳 Beijing, Beijing, China