Mass Balance Study in Healthy SubjectsPhase 1NCT05920941
Mass Balance Study of [14C]JAB-21822
A Phase 1 study testing [14C]JAB-21822 in people with Mass Balance Study in Healthy Subjects, run by Allist Pharmaceuticals, Inc. at 1 site in China.
Trial summary
Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mass Balance Study in Healthy Subjects
- What is being tested?
- [14C]JAB-21822
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2023to 9 Aug 2023
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 45 years (inclusive).
- Subjects weighing ≥ 50 kg and Body Mass Index of 19.0 to 26.0 kg/m2.
- Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.
Who cannot join
- With abnormal and clinically significant comprehensive physical examinations, vital signs, or laboratory examinations.
- Has a positive test for HBV, HCV, HIV, or syphilis.
- Known medical history judged by the investigator as not suitable for the study.
- Known history of drug or food allergy.
- Has drug or alcohol abuse history or positive drug or alcohol abuse test results.
- Heavy smokers or caffeine addicts.
Show all 9Show fewer
- Has diseases or other conditions affecting the absorption, distribution, metabolism, and excretion of oral drugs.
- Disagree to strict contraception within one year after the trial
- Has any other conditions judged by the investigator as not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects
Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects
Read the detailed description
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]JAB-21822
- Conditions
- Mass Balance Study in Healthy Subjects
- Being tested
- [14C]JAB-21822
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]JAB-21822Drug
Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach
| Study group | Role | What they receive |
|---|---|---|
| [14C]JAB-21822 | Experimental | Single oral dose of 800mg 14C]JAB-2182 suspension Receives: Drug: [14C]JAB-21822 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of total radioactivity in urine and fecal samples
Mass balance recovery of total radioactivity in urine and fecal samples
Measured: up to 504 hours post dose
Total radioactivity in plasma PK: Cmax
Highest radioactivity observed plasma concentration
Measured: up to 504 hours post dose
Total radioactivity in plasma PK: Area under the curve
Area under the plasma concentration time curve
Measured: up to 504 hours post dose
Total radioactivity in plasma PK: t1/2
Elimination half-life
Measured: up to 504 hours post dose
Total radioactivity in plasma PK: MRT
Mean residence time
Measured: up to 504 hours post dose
Total radioactivity in plasma PK: Tmax
Time for Cmax
Measured: up to 504 hours post dose
Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples
Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites
Measured: up to 504 hours post dose
Whole blood to plasma total radioactivity ratio
Measured: up to 504 hours post dose
Secondary outcomes (6)
JAB-21822 PK: Cmax
Highest observed plasma concentration of JAB-21822
Measured: up to 504 hours post dose
JAB-21822 PK: Area under the curve
Area under the plasma concentration time curve of JAB-21822
Measured: up to 504 hours post dose
JAB-21822 PK: t1/2
Elimination half-life of JAB-21822
Measured: up to 504 hours post dose
JAB-21822 PK: MRT
Mean residence time of JAB-21822
Measured: up to 504 hours post dose
JAB-21822 PK: Tmax
Time for Cmax of JAB-21822
Measured: up to 504 hours post dose
Number of participants with adverse events
All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms and ophthalmological assessments
Measured: up to 504 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start8 Jul 2023
- Primary completion9 Aug 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mass Balance Study in 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miao Liyan doctor of pharmacy, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920941
- Sponsor's protocol ID
- JAB-21822-1008
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 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
- Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects
- ClinicalTrials.gov ID
- NCT05920941
- Acronym / sponsor ID
- JAB-21822-1008
- Conditions
- Mass Balance Study in Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2023 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 27 Jun 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.
Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects
Detailed description
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]JAB-21822
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]JAB-21822 | Experimental | Drug: [14C]JAB-21822Single oral dose of 800mg 14C]JAB-2182 suspension |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects between the ages of 18 and 45 years (inclusive).
- Subjects weighing ≥ 50 kg and Body Mass Index of 19.0 to 26.0 kg/m2.
- Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.
Key exclusion criteria (9 listed)
- With abnormal and clinically significant comprehensive physical examinations, vital signs, or laboratory examinations.
- Has a positive test for HBV, HCV, HIV, or syphilis.
- Known medical history judged by the investigator as not suitable for the study.
- Known history of drug or food allergy.
- Has drug or alcohol abuse history or positive drug or alcohol abuse test results.
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 |
|---|---|---|
| [14C]JAB-21822Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach | Drug | [14C]JAB-21822 |
Primary outcome
Recovery of total radioactivity in urine and fecal samples
Time frame: up to 504 hours post dose
Mass balance recovery of total radioactivity in urine and fecal samples
Total radioactivity in plasma PK: Cmax
Time frame: up to 504 hours post dose
Highest radioactivity observed plasma concentration
Total radioactivity in plasma PK: Area under the curve
Time frame: up to 504 hours post dose
Area under the plasma concentration time curve
Total radioactivity in plasma PK: t1/2
Time frame: up to 504 hours post dose
Elimination half-life
Total radioactivity in plasma PK: MRT
Time frame: up to 504 hours post dose
Mean residence time
Total radioactivity in plasma PK: Tmax
Time frame: up to 504 hours post dose
Time for Cmax
Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples
Time frame: up to 504 hours post dose
Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites
Whole blood to plasma total radioactivity ratio
Time frame: up to 504 hours post dose
6 secondary outcomes
JAB-21822 PK: Cmax
Time frame: up to 504 hours post dose
JAB-21822 PK: Area under the curve
Time frame: up to 504 hours post dose
JAB-21822 PK: t1/2
Time frame: up to 504 hours post dose
JAB-21822 PK: MRT
Time frame: up to 504 hours post dose
JAB-21822 PK: Tmax
Time frame: up to 504 hours post dose
Number of participants with adverse events
Time frame: up to 504 hours post dose
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.
Miao Liyan doctor of pharmacy principal investigator
The First Affiliated Hospital of Soochow University
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 [14C]JAB-21822 in people with Mass Balance Study in 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 9 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?
Recovery of total radioactivity in urine and fecal samples (time frame: up to 504 hours post dose). The study lists 8 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.