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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Itraconazole; Drug: JAB-21822; Drug: Rifampicin; Drug: Omeprazole; Drug: Midazolam , Rosuvastatin calcium and digoxin

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102206
      • Beijing GoBroad Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JAB-21822+Itraconazole	Drug: Itraconazole; Itraconazole was administered orally; Drug: JAB-21822; JAB-21822 was administered orally
Experimental: JAB-21822+ Rifampicin	Drug: JAB-21822; JAB-21822 was administered orally; Drug: Rifampicin; Rifampicin was administered orally
Experimental: JAB-21822+ Omeprazole	Drug: JAB-21822; JAB-21822 was administered orally; Drug: Omeprazole; Omeprazole was administered orally
Experimental: Dazolam , Rosuvastatin calcium and digoxin with JAB-21822	Drug: JAB-21822; JAB-21822 was administered orally; Drug: Midazolam , Rosuvastatin calcium and digoxin; Midazolam , Rosuvastatin calcium and digoxin was administered orally

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Allist Pharmaceuticals, Inc.
• Investigators: Principal Investigator: He Qing B.Pharm, Beijing Gaobo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calcium-Regulating Hormones and Agents; Anti-Bacterial Agents; Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Antimetabolites; Nucleic Acid Synthesis Inhibitors; Anesthetics; Central Nervous System Depressants; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; GABA Modulators; GABA Agents; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Antibiotics, Antitubercular; Antitubercular Agents; Cytochrome P-450 CYP3A Inhibitors; Leprostatic Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Cytochrome P-450 CYP3A Inducers; 14-alpha Demethylase Inhibitors; Rosuvastatin Calcium; Calcium; Midazolam; Digoxin; Omeprazole; Rifampin; Itraconazole
• Other Study ID Numbers: JAB-21822-1010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No