Primary IgA Nephropathy; Autoimmune HepatitisPhase 1NCT06922305
Relative Bioavailability Study of HR19042 in Healthy Subjects
A Phase 1 study testing HR19042 Capsule, Tarpeyo®, Budenofalk® in people with Primary IgA Nephropathy; Autoimmune Hepatitis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, randomized, open-label, three-period, dual Latin square crossover study. Primary Objective： 1. To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary IgA Nephropathy; Autoimmune Hepatitis
- What is being tested?
- HR19042 Capsule, Tarpeyo®, Budenofalk®
- 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
- 27 Dec 2023to 25 Jan 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects, ages 18 to 45, inclusive, at the time of informed consent.
- Female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and BMI between 19.0 and 28.0 kg/m2, inclusive, at screening.
- Understands the study procedures in the informed consent form ICF and be willing and able to comply with the protocol.
Who cannot join
- Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician.
- Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
- Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.
- History of any gastrointestinal surgery or cholecystectomy that could impact the PK of study drugs.
- Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.
- Blood loss or blood donation of more than 300 mL within 3 months before screening, or intended to donate blood during the trial.
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- Those who have been vaccinated with vaccines within 3 month before screening or who have an intention to vaccinate during the trial.
- Difficulty in venous blood sampling or fear of needles/blood.
- Difficulty in swallowing capsules, or inability to comply with the provided diet and study-related instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Relative Bioavailability of HR19042 Capsules in Healthy Subjects
This is a single-center, randomized, open-label, three-period, dual Latin square crossover study.
Primary Objective：
- To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®). Secondary Objective
- To assess safety following administration.
- Being tested
- HR19042 Capsule, Tarpeyo®, Budenofalk®
- Medical subject headings
- Glomerulonephritis, IGA, Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR19042 Capsule, Tarpeyo®, Budenofalk®Drug
In each period under fasting conditions, subjects received oral administration of either HR19042 Capsule 16 mg, Tarpeyo® 16 mg, or Budenofalk® 15 mg.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: HR19042 Capsules Period 2: Tarpeyo® Period 3: Budenofalk® Receives: Drug: HR19042 Capsule, Tarpeyo®, Budenofalk® |
| Sequence 2 | Experimental | Period 1: Tarpeyo® Period 2: Budenofalk® Period 3: HR19042 Capsules Receives: Drug: HR19042 Capsule, Tarpeyo®, Budenofalk® |
| Sequence 3 | Experimental | Period 1: Budenofalk® Period 2: HR19042 Capsules Period 3: Tarpeyo® Receives: Drug: HR19042 Capsule, Tarpeyo®, Budenofalk® |
| Sequence 4 | Experimental | Period 1: Tarpeyo® Period 2: HR19042 Capsules Period 3: Budenofalk® Receives: Drug: HR19042 Capsule, Tarpeyo®, Budenofalk® |
| Sequence 5 | Experimental | Period 1: HR19042 Capsules Period 2: Budenofalk® Period 3: Tarpeyo® Receives: Drug: HR19042 Capsule, Tarpeyo®, Budenofalk® |
| Sequence 6 | Experimental | Period 1: Budenofalk® Period 2: Tarpeyo® Period 3: HR19042 Capsules Receives: Drug: HR19042 Capsule, Tarpeyo®, Budenofalk® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum plasma concentration. Blood samples will be collected.
Measured: From Day 1 up to Day 8
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Measured: From Day 1 up to Day 8
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Measured: From Day 1 up to Day 8
Tmax: Observed time to reach Cmax. Blood samples will be collected.
Measured: From Day 1 up to Day 8
Secondary outcomes (1)
Incidence of treatment emergent AEs (TEAEs)
Measured: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start27 Dec 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary IgA Nephropathy; Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922305
- Sponsor's protocol ID
- HR19042-103
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yin T, Zou J, Tang M, Yang M, Han Q, Jiang H, Hu H, Li X, Wu Y, Huang Y, He L. Comparison of the Pharmacokinetics of Three Budesonide Formulations in Healthy Chinese Subjects. Clin Pharmacol Drug Dev. 2026 Jan;15(1):e1603. doi: 10.1002/cpdd.1603. Epub 2025 Sep 12.
PubMed 40936477
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Relative Bioavailability of HR19042 Capsules in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06922305
- Acronym / sponsor ID
- HR19042-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 10 Apr 2025 (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 single-center, randomized, open-label, three-period, dual Latin square crossover study.
Primary Objective：
- To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®). Secondary Objective
- To assess safety following administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®Period 1: HR19042 Capsules Period 2: Tarpeyo® Period 3: Budenofalk® |
| Sequence 2 | Experimental | Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®Period 1: Tarpeyo® Period 2: Budenofalk® Period 3: HR19042 Capsules |
| Sequence 3 | Experimental | Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®Period 1: Budenofalk® Period 2: HR19042 Capsules Period 3: Tarpeyo® |
| Sequence 4 | Experimental | Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®Period 1: Tarpeyo® Period 2: HR19042 Capsules Period 3: Budenofalk® |
| Sequence 5 | Experimental | Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®Period 1: HR19042 Capsules Period 2: Budenofalk® Period 3: Tarpeyo® |
| Sequence 6 | Experimental | Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®Period 1: Budenofalk® Period 2: Tarpeyo® Period 3: HR19042 Capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female subjects, ages 18 to 45, inclusive, at the time of informed consent.
- Female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and BMI between 19.0 and 28.0 kg/m2, inclusive, at screening.
- Understands the study procedures in the informed consent form ICF and be willing and able to comply with the protocol.
Key exclusion criteria (9 listed)
- Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician.
- Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
- Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.
- History of any gastrointestinal surgery or cholecystectomy that could impact the PK of study drugs.
- Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.
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 |
|---|---|---|
| HR19042 Capsule, Tarpeyo®, Budenofalk®In each period under fasting conditions, subjects received oral administration of either HR19042 Capsule 16 mg, Tarpeyo® 16 mg, or Budenofalk® 15 mg. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Cmax: Maximum plasma concentration. Blood samples will be collected.
Time frame: From Day 1 up to Day 8
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Time frame: From Day 1 up to Day 8
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Time frame: From Day 1 up to Day 8
Tmax: Observed time to reach Cmax. Blood samples will be collected.
Time frame: From Day 1 up to Day 8
1 secondary outcome
Incidence of treatment emergent AEs (TEAEs)
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 14)
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 22 Apr 2025.
- Derived from this study: PubMed 40936477Yin T, Zou J, Tang M, Yang M, Han Q, Jiang H, Hu H, Li X, Wu Y, Huang Y, He L. Comparison of the Pharmacokinetics of Three Budesonide Formulations in Healthy Chinese Subjects. Clin Pharmacol Drug Dev. 2026 Jan;15(1):e1603. doi: 10.1002/cpdd.1603. Epub 2025 Sep 12.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 HR19042 Capsule, Tarpeyo®, Budenofalk® in people with Primary IgA Nephropathy; Autoimmune Hepatitis, run by Jiangsu HengRui Medicine Co., Ltd. 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 22 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?
Cmax: Maximum plasma concentration. Blood samples will be collected. (time frame: From Day 1 up to Day 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06922305, which also lists 1 linked publication.
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 22 Apr 2025.