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Completed

NCT Number: NCT06162169

A 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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102206, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ；Healthy subjects aged 18 to 50 years (including both ends) at the time of signing informed consent
  • 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.
  • Subjects voluntarily signed written informed consent and were able to communicate well with the investigator

Exclusion criteria

  • History of severe systemic diseases, history of liver and kidney insufficiency, history of mental illness, history of drug dependence;
  • Patients with a history of interstitial pneumonia, pulmonary fibrosis or other interstitial lung diseases who were not eligible for admission by the investigators;
  • 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;
  • The investigator believes that the subject has any other circumstances that make him or her unfit to participate in this clinical trial

Treatment and study plan

JAB-21822

Drug

JAB-21822 was administered orally

Itraconazole

Drug

Itraconazole was administered orally

Omeprazole

Drug

Omeprazole was administered orally

Midazolam , Rosuvastatin calcium and digoxin

Drug

Midazolam , Rosuvastatin calcium and digoxin was administered orally

rifampicin

Drug

Rifampicin was administered orally

Primary outcomes

  1. Observed maximum concentrations (Cmax )of JAB-21822

    Time frame: approximately 10 days

  2. Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822

    Time frame: approximately 10 days

  3. Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822

    Time frame: approximately 10 days

  4. Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin

    Time frame: approximately 10 days

  5. Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin

    Time frame: approximately 10 days

  6. Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin

    Time frame: approximately 10 days

Sponsors and collaborators

Lead sponsor

Allist Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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