Healthy SubjectsPhase 1NCT06162169
A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
A Phase 1 study testing JAB-21822, Itraconazole and Omeprazole in people with Healthy Subjects, run by Allist Pharmaceuticals, Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- JAB-21822, Itraconazole and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2023to 20 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Subjects
- Being tested
- JAB-21822, Itraconazole, Omeprazole, Midazolam , Rosuvastatin calcium and digoxin, Rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-21822Drug
JAB-21822 was administered orally
ItraconazoleDrug
Itraconazole was administered orally
OmeprazoleDrug
Omeprazole was administered orally
Midazolam , Rosuvastatin calcium and digoxinDrug
Midazolam , Rosuvastatin calcium and digoxin was administered orally
RifampicinDrug
Rifampicin was administered orally
| Study group | Role | What they receive |
|---|---|---|
| JAB-21822+Itraconazole | Experimental | Not described Receives: Drug: JAB-21822; Drug: Itraconazole |
| JAB-21822+ Rifampicin | Experimental | Not described Receives: Drug: JAB-21822; Drug: Rifampicin |
| JAB-21822+ Omeprazole | Experimental | Not described Receives: Drug: JAB-21822; Drug: Omeprazole |
| Dazolam , Rosuvastatin calcium and digoxin with JAB-21822 | Experimental | Not described Receives: Drug: JAB-21822; Drug: Midazolam , Rosuvastatin calcium and digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed maximum concentrations (Cmax )of JAB-21822
Measured: approximately 10 days
Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822
Measured: approximately 10 days
Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822
Measured: approximately 10 days
Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin
Measured: approximately 10 days
Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin
Measured: approximately 10 days
Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin
Measured: approximately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start25 Nov 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- He Qing B.Pharm, Principal investigator, Beijing Gaobo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162169
- Sponsor's protocol ID
- JAB-21822-1010
- Status last verified
- Jun 2024
- First submitted
- 29 Nov 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Non-randomized, Open-lable, Self-controlled Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06162169
- Acronym / sponsor ID
- JAB-21822-1010
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JAB-21822+Itraconazole | Experimental | Drug: JAB-21822, Drug: Itraconazole |
| JAB-21822+ Rifampicin | Experimental | Drug: JAB-21822, Drug: Rifampicin |
| JAB-21822+ Omeprazole | Experimental | Drug: JAB-21822, Drug: Omeprazole |
| Dazolam , Rosuvastatin calcium and digoxin with JAB-21822 | Experimental | Drug: JAB-21822, Drug: Midazolam , Rosuvastatin calcium and digoxin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAB-21822JAB-21822 was administered orally | Drug | Dazolam , Rosuvastatin calcium and digoxin with JAB-21822, JAB-21822+ Omeprazole, JAB-21822+ Rifampicin, JAB-21822+Itraconazole |
| ItraconazoleItraconazole was administered orally | Drug | JAB-21822+Itraconazole |
| OmeprazoleOmeprazole was administered orally | Drug | JAB-21822+ Omeprazole |
| Midazolam , Rosuvastatin calcium and digoxinMidazolam , Rosuvastatin calcium and digoxin was administered orally | Drug | Dazolam , Rosuvastatin calcium and digoxin with JAB-21822 |
| RifampicinRifampicin was administered orally | Drug | JAB-21822+ Rifampicin |
Primary outcome
Observed maximum concentrations (Cmax )of JAB-21822
Time frame: approximately 10 days
Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822
Time frame: approximately 10 days
Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822
Time frame: approximately 10 days
Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin
Time frame: approximately 10 days
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
Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin
Time frame: approximately 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Qing B.Pharm principal investigator
Beijing Gaobo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JAB-21822, Itraconazole and Omeprazole in people with Healthy Subjects, run by Allist Pharmaceuticals, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed maximum concentrations (Cmax )of JAB-21822 (time frame: approximately 10 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.