IgA NephropathyPhase 1NCT07897240
A Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants
A Phase 1 study testing Budesonide delayed release tablet in people with IgA Nephropathy, run by Triastek, lnc. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effect of food (a high-fat, high-calorie meal) on the PK of a single oral dose of budesonide delayed release tablet in healthy participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Budesonide delayed release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully understand the purpose, nature, procedures of the study and possible adverse reactions, voluntarily participate in the study, and sign the informed consent form (ICF) before any study procedures begin;
- Healthy male or female participants aged ≥18 years;
- Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index (BMI) in the range of 18.5 to 24.9 kg/m2 (inclusive);
- Voluntarily use effective contraception during the study and for 3 months after the last dose of the investigational product, and have no plans for childbirth, sperm donation, or egg donation;
- Able to communicate well with the investigator and understand and comply with all requirements of this study.
Who cannot join
- Allergic diathesis, a clinical history of allergies to food, drugs, etc., or a known history of allergy to budesonide, budesonide delayed release tablet, or excipients of budesonide delayed release capsules;
- History of chronic or serious diseases of the cardiovascular, hepatic, renal, biliary, respiratory, hematologic and lymphatic, endocrine, immune, psychiatric, neuromuscular, or gastrointestinal systems within one year prior to screening until randomization;
- History of gastrointestinal diseases (including current) from one year prior to screening until randomization, including chronic or active upper gastrointestinal diseases such as esophageal disorder, gastritis, duodenitis, ulcer, or active gastrointestinal hemorrhage or gastrointestinal surgery;
- Have had or currently have infectious diseases within 1 month prior to screening, including fungal/bacterial/viral/parasitic infections, ocular herpes simplex, varicella, measles, etc.;
- Have a history of or currently have eye disorders (such as glaucoma, cataracts), or have a family history of glaucoma;
- Have clinically significant abnormal results in vital signs, physical examination, clinical laboratory tests (hematology, urinalysis, clinical chemistry, 4-item coagulation test, 4-item infectious disease test) and ECG at screening, as judged by the investigator;
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- Have had acute diseases within 2 weeks prior to screening until randomization (including acute appendicitis, acute gastroenteritis, acute cerebral infarction, cerebral hemorrhage, angina pectoris, upper gastrointestinal hemorrhage, etc.);
- Have the following ECG findings at screening: prolonged QTcF interval (QTcF>450 ms for males, >470 ms for females);
- Have used any drugs (including any prescription drugs, over-the-counter drugs, Chinese herbal preparations) or health supplements from 2 weeks prior to screening until randomization;
- Have undergone major surgery (excluding diagnostic surgery) from 6 months prior to screening until randomization, or have undergone surgery that, in the investigator's judgment, would affect the absorption, distribution, metabolism, or excretion of the drug, or are planning to undergo surgery during the study;
- Have an average weekly alcohol use of more than 14 units (1 unit = 360 mL of 5% alcohol beer or 45 mL of 40% alcohol spirits or 150 mL of 12% alcohol wine) from 3 months prior to screening until randomization, or are unable to abstain from alcohol during the study, or have an alcohol breath test result greater than 0.0 mg/100 mL;
- Have consumed tea, coffee, or beverages containing caffeine or alcohol from 48 hours before dosing until randomization, or are unable to stop consuming them during the study;
- Have consumed foods or beverages that affect drug metabolism, such as chocolate, dragon fruit, mango, carambola, guava, pomelo, orange, grapefruit or grapefruit products, from 48 hours before dosing until randomization, or are unable to stop consuming them during the study;
- Have received any vaccine from 4 weeks prior to screening until randomization, or plan to receive any vaccine during the study (by inquiry);
- Have participated in any drug or device clinical study from 3 months prior to screening until randomization (participation is defined as receiving the investigational drug or device, and the end time is defined as the date of discharge from the last clinical study);
- Have a history of blood donation from 3 months prior to screening until randomization, or have a total blood loss of 400 mL or more from blood donation or other reasons within 6 months (excluding menstrual blood loss for females), or plan to donate blood within 6 months after the last blood collection;
- Have an average daily smoking of more than 5 cigarettes from 3 months prior to screening until randomization, or are unable to stop using any tobacco products during the study;
- Have a history of drug addiction or drug abuse (including non-medical use of various narcotic drugs and psychotropic drugs);
- Have a positive result for any item in the urine drug screen (including: morphine, methamphetamine (ice), ketamine (K powder), ecstasy (MDMA), marijuana (tetrahydrocannabinolic acid), etc.);
- Have difficulty with venipuncture or poor vascular conditions, or cannot tolerate venipuncture/indwelling needle, or have a history of fainting from needles or blood;
- Have lactose intolerance;
- Have special dietary requirements, or are unable to accept the standardized diet during the study;
- Have dysphagia;
- Be unsuitable for enrollment or other situations where the participant is unable to participate for personal reasons as judged by the investigator.
- Female participants who meet the following conditions, in addition to the above requirements, should also be excluded:
- Have used oral contraception from 30 days prior to screening until randomization;
- Have used long-acting estrogen or progesterone injections (including progesterone-releasing intrauterine devices) or implants from 6 months prior to screening until randomization;
- Have had unprotected sexual intercourse with a partner from 14 days prior to screening until randomization;
- Have a positive pregnancy test;
- Are women who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Meng Wang, +8613656226596, sdfeyyq_wm@163.com
About this study
Official title: A Single-Center, Randomized, Open-Label, Single-Dose, Two-Period, Two-Crossover Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants
The goal of this clinical trial is to evaluate the effect of food (a high-fat, high-calorie meal) on the PK of a single oral dose of budesonide delayed release tablet in healthy participants. The main questions it aims to answer are :
(1) Does a high-fat, high-calorie meal significantly alter the plasma exposure (Cmax, AUC) of budesonide following oral administration of D23A? ( 2) How does food intake affect the absorption rate (Tmax, Tlag) and other PK parameters of D23A? Researchers will compare the plasma PK parameters of D23A administered under fasted conditions versus fed conditions to see if a high-fat, high-calorie meal has a significant impact on the bioavailability and absorption kinetics of D23A .
Participants will receive a single oral dose of 16 mg D23A (4 tablets) in each period of the crossover study, with one period under fasted conditions and the other under fed conditions (after consuming a high-fat, high-calorie meal) . The study will also monitor and record any adverse events (AEs) to evaluate the safety and tolerability of D23A under fed conditions .
- Conditions
- IgA Nephropathy
- Being tested
- Budesonide delayed release tablet
- Keywords
- Budesonide Delayed-Release Tablets
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide delayed release tabletDrug
3D printing tablets
| Study group | Role | What they receive |
|---|---|---|
| Fasted-Fed group | Experimental | Period 1: Fasted, 5-days washout period, period 2: Fed Receives: Drug: Budesonide delayed release tablet |
| Fed-Fasted group | Experimental | Period 1: Fed, 5-day washout period, period 2: Fasted Receives: Drug: Budesonide delayed release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Primary PK parameters
Measured: up to 48 hours post-dose
AUC0-t
Primary PK parameters
Measured: up to 48 hours post-dose
AUC0-∞
Primary PK parameters
Measured: up to 48 hours post-dose
Tmax
Secondary PK parameters
Measured: up to 48 hours post-dose
Tlag
Secondary PK parameters
Measured: up to 48 hours post-dose
AUC0-4
Secondary PK parameters
Measured: up to 48 hours post-dose
AUC4-t
Secondary PK parameters
Measured: up to 48 hours post-dose
t1/2
Secondary PK parameters
Measured: up to 48 hours post-dose
λz
Secondary PK parameters
Measured: up to 48 hours post-dose
AUC_%Extrap
Secondary PK parameters
Measured: up to 48 hours post-dose
CL/F
Secondary PK parameters
Measured: up to 48 hours post-dose
VZ/F
Secondary PK parameters
Measured: up to 48 hours post-dose
Secondary outcomes (1)
Incidence of adverse events (AEs) during the study
Measured: Through study completion, an average of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- 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
- Two-Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Triastek, lnc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897240
- Sponsor's protocol ID
- D23A-102
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Open-Label, Single-Dose, Two-Period, Two-Crossover Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07897240
- Acronym / sponsor ID
- D23A-102
- Conditions
- IgA Nephropathy
- Keywords
- Budesonide Delayed-Release Tablets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Triastek, lnc.Industry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital of Soochow University
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Oct 2026 (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 goal of this clinical trial is to evaluate the effect of food (a high-fat, high-calorie meal) on the PK of a single oral dose of budesonide delayed release tablet in healthy participants. The main questions it aims to answer are :
(1) Does a high-fat, high-calorie meal significantly alter the plasma exposure (Cmax, AUC) of budesonide following oral administration of D23A? ( 2) How does food intake affect the absorption rate (Tmax, Tlag) and other PK parameters of D23A? Researchers will compare the plasma PK parameters of D23A administered under fasted conditions versus fed conditions to see if a high-fat, high-calorie meal has a significant impact on the bioavailability and absorption kinetics of D23A .
Participants will receive a single oral dose of 16 mg D23A (4 tablets) in each period of the crossover study, with one period under fasted conditions and the other under fed conditions (after consuming a high-fat, high-calorie meal) . The study will also monitor and record any adverse events (AEs) to evaluate the safety and tolerability of D23A under fed conditions .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-Crossover
| Arm | Type | Receives |
|---|---|---|
| Fasted-Fed group | Experimental | Drug: Budesonide delayed release tabletPeriod 1: Fasted, 5-days washout period, period 2: Fed |
| Fed-Fasted group | Experimental | Drug: Budesonide delayed release tabletPeriod 1: Fed, 5-day washout period, period 2: Fasted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully understand the purpose, nature, procedures of the study and possible adverse reactions, voluntarily participate in the study, and sign the informed consent form (ICF) before any study procedures begin;
- Healthy male or female participants aged ≥18 years;
- Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index (BMI) in the range of 18.5 to 24.9 kg/m2 (inclusive);
- Voluntarily use effective contraception during the study and for 3 months after the last dose of the investigational product, and have no plans for childbirth, sperm donation, or egg donation;
- Able to communicate well with the investigator and understand and comply with all requirements of this study.
Key exclusion criteria (30 listed)
- Allergic diathesis, a clinical history of allergies to food, drugs, etc., or a known history of allergy to budesonide, budesonide delayed release tablet, or excipients of budesonide delayed release capsules;
- History of chronic or serious diseases of the cardiovascular, hepatic, renal, biliary, respiratory, hematologic and lymphatic, endocrine, immune, psychiatric, neuromuscular, or gastrointestinal systems within one year prior to screening until randomization;
- History of gastrointestinal diseases (including current) from one year prior to screening until randomization, including chronic or active upper gastrointestinal diseases such as esophageal disorder, gastritis, duodenitis, ulcer, or active gastrointestinal hemorrhage or gastrointestinal surgery;
- Have had or currently have infectious diseases within 1 month prior to screening, including fungal/bacterial/viral/parasitic infections, ocular herpes simplex, varicella, measles, etc.;
- Have a history of or currently have eye disorders (such as glaucoma, cataracts), or have a family history of glaucoma;
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 |
|---|---|---|
| Budesonide delayed release tablet3D printing tablets | Drug | Fasted-Fed group, Fed-Fasted group |
Primary outcome
Cmax
Time frame: up to 48 hours post-dose
Primary PK parameters
AUC0-t
Time frame: up to 48 hours post-dose
Primary PK parameters
AUC0-∞
Time frame: up to 48 hours post-dose
Primary PK parameters
Tmax
Time frame: up to 48 hours post-dose
Secondary PK parameters
Tlag
Time frame: up to 48 hours post-dose
Secondary PK parameters
AUC0-4
Time frame: up to 48 hours post-dose
Secondary PK parameters
AUC4-t
Time frame: up to 48 hours post-dose
Secondary PK parameters
t1/2
Time frame: up to 48 hours post-dose
Secondary PK parameters
λz
Time frame: up to 48 hours post-dose
Secondary PK parameters
AUC_%Extrap
Time frame: up to 48 hours post-dose
Secondary PK parameters
CL/F
Time frame: up to 48 hours post-dose
Secondary PK parameters
VZ/F
Time frame: up to 48 hours post-dose
Secondary PK parameters
1 secondary outcome
Incidence of adverse events (AEs) during the study
Time frame: Through study completion, an average of 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Budesonide delayed release tablet in people with IgA Nephropathy, run by Triastek, lnc. 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 5 inclusion and 30 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiuzhu Dong (+8615715152621, dongqiuzhu@triastek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: up to 48 hours post-dose). The study lists 12 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 27 Oct 2026.