Food Effect in Healthy ParticipantsPhase 1NCT05875493
A Food Effect Study of JAB-21822 in Healthy Subjects
A Phase 1 study testing JAB-21822 in people with Food Effect in Healthy Participants, run by Allist Pharmaceuticals, Inc. at 1 site in China.
Trial summary
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of JAB-21822 following single dose administration with and without a meal Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Effect in Healthy Participants
- What is being tested?
- JAB-21822
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 14 Jun 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female , between 18 and 45 years of age
- Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg；BMI within the range of 19 to 25 kg/m2, inclusive
- No clinically significant abnormalities identified in the judgement of investigator at screening
- Written informed consent prior to any study specific procedures
Who cannot join
- History of clinically significant disease or disorder
- History of interstitial pneumonia, pulmonary fibrosis, and other interstitial lung diseases
- History of dysphagia or any gastrointestinal disease that would potentially alter absorption of drug
- COVID-19 positive at screening or baseline
- Allergic to JAB-21822 and any of the tablet's ingredients, history of hypersensitivity or allergy to drug or food
- Received surgical procedure within 3 months at screening
Show all 15Show fewer
- Blood donation within the 3 months or planing to donate during the study
- Participated in another clinical trial of biological agents within 6 months at screening, or any other clinical trial within 3 months at screening
- History of drug abuse or positive urine drug test
- Received the vaccine within 3 months at screening or planning to receive during the study
- Overtake of achole,tea and coffee prior to first dosing and unable to control during the study
- Special dietary requirements or unable to control during the study
- HIV, HBV, HCV, and syphilis positive
- Pregnant or breast-feeding women or positive of blood pregnancy test
- Subjects who are considered to be unacceptable in this study under the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, 100070
About this study
Official title: A Phase I, Single-center, Randomized, Open-label, 2-cycle,2-period Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of JAB-21822 in Healthy Subjects
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of JAB-21822 following single dose administration with and without a meal
Read the detailed description
This is an open-label,randomized, 2-cycle,2-period crossover,food effect study. On Day 1 of each period, subjects will receive a single oral dose of JAB-21822 administered either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for JAB-21822 will be collected predose and postdose. There will be a washout period between doses.
- Conditions
- Food Effect in Healthy Participants
- Being tested
- JAB-21822
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-21822Drug
2 discrete single doses
JAB-21822Drug
2 discrete single doses
| Study group | Role | What they receive |
|---|---|---|
| A-JAB-21822 | Experimental | Dosing in the fasted state followed by fed dosing Receives: Drug: JAB-21822 |
| B-JAB-21822 | Experimental | Dosing in the fed state followed by fasted dosing Receives: Drug: JAB-21822 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration (AUC) 0 to∞
Area under the plasma concentration time curve of JAB-21822
Measured: 31days
Area under plasma concentration (AUC) 0 to t
Area under the plasma concentration time curve of JAB-21822
Measured: 31days
Plasma concentration ( Cmax)
Highest observed plasma concentration of JAB-21822
Measured: 31days
Secondary outcomes (13)
Time to achieve Cmax (Tmax)
Time of highest observed plasma concentration of JAB-21822
Measured: 31days
Elimination rate constant (λz)
Elimination rate constant based on the terminal phase of unchanged form of JAB-21822
Measured: 31days
Concentration half-life (T1/2)
Elimination half-life of unchanged form of JAB-21822
Measured: 31days
Absorption lag-time (Tlag)
Elimination lag-time of JAB-21822
Measured: 31days
Apparent volume of distribution (Vz/F)
Apparent volume of distribution based on the terminal phase of unchanged form of JAB-21822
Measured: 31days
Apparent clearance (CL/F)
Apparent total body clearance of unchanged form of JAB-21822
Measured: 31days
Number of participants with adverse events (AEs) and serious adverse events(SAEs)
Incidence,duration and severity of adverse events and serious adverse events according to NCI-CTCAE v5.0
Measured: 31days
Number of subjects with abnormal lab parameters
Abnormal values of lab parameters
Measured: 31days
Number of subjects with abnormal electrocardiogram (12-lead ECG)
Prolongation of the QTc interval
Measured: 31days
Number of subjects with abnormal systolic and diastolic blood pressure
Abnormal values in systolic and diastolic blood pressure
Measured: 31days
Number of subjects with abnormal pulse rate
Abnormal values in pulse rate
Measured: 31days
Number of subjects with abnormal respiratory rate
Abnormal values in respiratory rate
Measured: 31days
Number of subjects with abnormal body temperature
Abnormal values of body temperature
Measured: 31days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start12 May 2023
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Effect in Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an open-label,randomized, 2-cycle,2-period crossover,food effect study
- Masking
- None (open label)
- Enrolment
- 18 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 Boren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875493
- Sponsor's protocol ID
- JAB-21822-1009
- Status last verified
- Jan 2024
- First submitted
- 23 Apr 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 Phase I, Single-center, Randomized, Open-label, 2-cycle,2-period Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of JAB-21822 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05875493
- Acronym / sponsor ID
- JAB-21822-1009
- Conditions
- Food Effect in Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2023 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 25 May 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.
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of JAB-21822 following single dose administration with and without a meal
Detailed description
This is an open-label,randomized, 2-cycle,2-period crossover,food effect study. On Day 1 of each period, subjects will receive a single oral dose of JAB-21822 administered either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for JAB-21822 will be collected predose and postdose. There will be a washout period between doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label,randomized, 2-cycle,2-period crossover,food effect study
| Arm | Type | Receives |
|---|---|---|
| A-JAB-21822 | Experimental | Drug: JAB-21822Dosing in the fasted state followed by fed dosing |
| B-JAB-21822 | Experimental | Drug: JAB-21822Dosing in the fed state followed by fasted dosing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female , between 18 and 45 years of age
- Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg；BMI within the range of 19 to 25 kg/m2, inclusive
- No clinically significant abnormalities identified in the judgement of investigator at screening
- Written informed consent prior to any study specific procedures
Key exclusion criteria (15 listed)
- History of clinically significant disease or disorder
- History of interstitial pneumonia, pulmonary fibrosis, and other interstitial lung diseases
- History of dysphagia or any gastrointestinal disease that would potentially alter absorption of drug
- COVID-19 positive at screening or baseline
- Allergic to JAB-21822 and any of the tablet's ingredients, history of hypersensitivity or allergy to drug or food
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-218222 discrete single doses | Drug | A-JAB-21822 |
| JAB-218222 discrete single doses | Drug | B-JAB-21822 |
Primary outcome
Area under plasma concentration (AUC) 0 to∞
Time frame: 31days
Area under the plasma concentration time curve of JAB-21822
Area under plasma concentration (AUC) 0 to t
Time frame: 31days
Area under the plasma concentration time curve of JAB-21822
Plasma concentration ( Cmax)
Time frame: 31days
Highest observed plasma concentration of JAB-21822
13 secondary outcomes
Time to achieve Cmax (Tmax)
Time frame: 31days
Elimination rate constant (λz)
Time frame: 31days
Concentration half-life (T1/2)
Time frame: 31days
Absorption lag-time (Tlag)
Time frame: 31days
Apparent volume of distribution (Vz/F)
Time frame: 31days
Apparent clearance (CL/F)
Time frame: 31days
Number of participants with adverse events (AEs) and serious adverse events(SAEs)
Time frame: 31days
Number of subjects with abnormal lab parameters
Time frame: 31days
Number of subjects with abnormal electrocardiogram (12-lead ECG)
Time frame: 31days
Number of subjects with abnormal systolic and diastolic blood pressure
Time frame: 31days
Number of subjects with abnormal pulse rate
Time frame: 31days
Number of subjects with abnormal respiratory rate
Time frame: 31days
Number of subjects with abnormal body temperature
Time frame: 31days
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 Boren 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 in people with Food Effect in Healthy Participants, 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 4 inclusion and 15 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?
Area under plasma concentration (AUC) 0 to∞ (time frame: 31days). The study lists 3 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.