NCT06162169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

April 4, 2025

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

November 29, 2023

Last Update Submit

April 3, 2025

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (4)

JAB-21822+Itraconazole

EXPERIMENTAL
Drug: JAB-21822Drug: Itraconazole

JAB-21822+ Rifampicin

EXPERIMENTAL
Drug: JAB-21822Drug: Rifampicin

JAB-21822+ Omeprazole

EXPERIMENTAL
Drug: JAB-21822Drug: Omeprazole

Dazolam , Rosuvastatin calcium and digoxin with JAB-21822

EXPERIMENTAL
Drug: JAB-21822Drug: Midazolam , Rosuvastatin calcium and digoxin

Interventions

JAB-21822DRUG

JAB-21822 was administered orally

Dazolam , Rosuvastatin calcium and digoxin with JAB-21822JAB-21822+ OmeprazoleJAB-21822+ RifampicinJAB-21822+Itraconazole
ItraconazoleDRUG

Itraconazole was administered orally

JAB-21822+Itraconazole
OmeprazoleDRUG

Omeprazole was administered orally

JAB-21822+ Omeprazole
Midazolam , Rosuvastatin calcium and digoxinDRUG

Midazolam , Rosuvastatin calcium and digoxin was administered orally

Dazolam , Rosuvastatin calcium and digoxin with JAB-21822
RifampicinDRUG

Rifampicin was administered orally

JAB-21822+ Rifampicin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102206, China

Location

MeSH Terms

Interventions

ItraconazoleOmeprazoleMidazolamRosuvastatin CalciumDigoxinRifampin

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzodiazepinesBenzazepinesSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesPyrimidinesDigitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydratesRifamycinsHeterocyclic Compounds, 4 or More RingsLactams, MacrocyclicMacrocyclic Compounds

Study Officials

  • He Qing B.Pharm

    Beijing Gaobo Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 8, 2023

Study Start

November 25, 2023

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

April 4, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)