Primary IgA NephropathyPhase 1NCT04887532
A Trial of HR19042 Capsule in Healthy Chinese Subjects
A Phase 1 study testing HR19042 capsule in people with Primary IgA Nephropathy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety and pharmacokinetics of HR19042 capsule after single administration in healthy Chinese subjects. To explore the pharmacokinetic characteristics and safety of HR19042 capsule in healthy Chinese subjects. 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
- What is being tested?
- HR19042 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 27 Jul 2021
- 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
- Age 18 ~ 45 years old, including boundary value;
- Female subjects weigh ≥45kg, male subjects weigh ≥50kg, and body mass index (BMI) is within the range of 19.0~26.0kg/m2 (body mass index = weight (kg)/height 2 (m2)), including boundary values;
- The subject has no plans to give birth or donate sperm/eggs for at least 3 months from the signing of the informed consent form to the end of the study, and voluntarily take effective non-drug contraceptive measures (including partners) during the trial period;
- Before the test, learn more about the nature, significance, possible benefits, possible inconvenience and potential risks of the test. Able to understand the procedures and methods of this research, willing to strictly abide by the clinical trial protocol to complete the trial, and voluntarily sign an informed consent form.
Who cannot join
- People with a known history of drug or food allergies;
- Past or current history of any disease that may affect the safety of subjects participating in the trial or the internal process of the research drug, including: digestive system, blood system, circulatory system, urinary system, respiratory system, nervous system, immune system, endocrine system, Those with a clear history of mental disorders and metabolic disorders, or other diseases that are not suitable for participating in clinical trials;
- Those who have used drugs that affect the function of liver metabolic enzyme CYP3A4 within 30 days before the first administration (such as inducers-enzalutamide, mitotane, carbamazepine, phenytoin, rifampin; inhibitors-clarithromycin, irradian) Traconazole, ketoconazole, ritonavir, telithromycin, etc.), or those who have used contraceptives within 30 days before administration;
- Those who have used any drug within 14 days before the first dose;
- Those who have taken a special diet (including grapefruit/grapefruit juice, chocolate, food or beverages containing caffeine) within 48 hours before the first administration, or have consumed excessive amounts of tea, coffee or beverages containing caffeine every day for the past 1 month (Average more than 8 cups per day, 200 mL per cup);
- Participate in drug clinical trials and take trial drugs as subjects within 3 months before screening, or plan to participate in other clinical trials during the study period;
Show all 21Show fewer
- Those who donated blood or lost more than 400 mL (excluding menstrual blood loss in women) within 3 months before screening, received blood transfusion or used blood products, or planned to donate blood during the trial period or within 1 month after the end of the trial;
- Those who have undergone major surgery within 3 months before screening, or plan to undergo surgery during the study period;
- Those who smoked more than 5 cigarettes a day on average in the 3 months before screening, or who did not agree to ban smoking during the trial;
- In the 6 months before screening, the average weekly alcohol consumption exceeded 14 units of alcohol (1 unit = 360 mL of beer with 5% alcohol content or 45 mL of spirits with 40% alcohol content or 150 mL of wine with 12% alcohol content), Or those who do not agree to abstain from alcohol during the trial;
- The results of laboratory tests (blood routine, urine routine, blood biochemistry, blood coagulation function) are judged by clinicians as abnormal and clinically significant;
- Those whose 12-lead ECG, physical examination or vital signs examination results are judged by clinicians as abnormal and clinically meaningful;
- Immunological examinations (hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, Treponema pallidum antibody) are positive;
- Those with abnormal chest radiograph (posterior anterior position) and clinical significance;
- Women who are pregnant or breastfeeding;
- Those who have a positive alcohol breath test;
- Those who have a positive urine drug screening;
- Those who have a history of drug abuse or drug abuse;
- People with a history of difficulty in venous blood collection, intolerance to venipuncture, or a history of fainting needles
- Those who have difficulty swallowing, or have special dietary requirements and cannot follow a uniform diet;
- The investigator believes that the subject has any other factors that are not suitable for participating in this trial (such as inability to understand the research requirements, poor compliance, infirmity, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200231
About this study
Official title: Safety and Pharmacokinetics of HR19042 Capsule After Single Administration in Healthy Chinese Subjects
The study is being conducted to evaluate the safety and pharmacokinetics of HR19042 capsule after single administration in healthy Chinese subjects. To explore the pharmacokinetic characteristics and safety of HR19042 capsule in healthy Chinese subjects.
- Conditions
- Primary IgA Nephropathy
- Being tested
- HR19042 capsule
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR19042 capsuleDrug
phase 1 :8mg; phase 2:12mg; phase 3:16mg
| Study group | Role | What they receive |
|---|---|---|
| HR19042 capsule | Experimental | Not described Receives: Drug: HR19042 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak concentration of drug observed from 0 hour to 24 hours after administration
Measured: 0-24 hours
AUC0-t;
The area under the drug concentration-time curve at the sample collection time t that can be accurately determined from 0 hour to 24 hours after administration
Measured: 0-24 hours
AUC0-∞
The area under the concentration-time curve of drug from 0 hour to infinity after administration
Measured: 0 hour to 24 hours
Secondary outcomes (2)
AE
Adverse event
Measured: Screening period to end of follow-up period, approximately 1 month
the change of blood cortisol AUC0-24h from baseline after each cycle of administration
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Jul 2021
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary IgA NephropathyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, open, three-period, sequential design
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT04887532
- Sponsor's protocol ID
- HR19042-101
- Status last verified
- May 2021
- First submitted
- 13 May 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of HR19042 Capsule After Single Administration in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04887532
- Acronym / sponsor ID
- HR19042-101
- Conditions
- Primary IgA Nephropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 14 May 2021 (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 study is being conducted to evaluate the safety and pharmacokinetics of HR19042 capsule after single administration in healthy Chinese subjects. To explore the pharmacokinetic characteristics and safety of HR19042 capsule in healthy Chinese subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, open, three-period, sequential design
| Arm | Type | Receives |
|---|---|---|
| HR19042 capsule | Experimental | Drug: HR19042 capsule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 ~ 45 years old, including boundary value;
- Female subjects weigh ≥45kg, male subjects weigh ≥50kg, and body mass index (BMI) is within the range of 19.0~26.0kg/m2 (body mass index = weight (kg)/height 2 (m2)), including boundary values;
- The subject has no plans to give birth or donate sperm/eggs for at least 3 months from the signing of the informed consent form to the end of the study, and voluntarily take effective non-drug contraceptive measures (including partners) during the trial period;
- Before the test, learn more about the nature, significance, possible benefits, possible inconvenience and potential risks of the test. Able to understand the procedures and methods of this research, willing to strictly abide by the clinical trial protocol to complete the trial, and voluntarily sign an informed consent form.
Key exclusion criteria (21 listed)
- People with a known history of drug or food allergies;
- Past or current history of any disease that may affect the safety of subjects participating in the trial or the internal process of the research drug, including: digestive system, blood system, circulatory system, urinary system, respiratory system, nervous system, immune system, endocrine system, Those with a clear history of mental disorders and metabolic disorders, or other diseases that are not suitable for participating in clinical trials;
- Those who have used drugs that affect the function of liver metabolic enzyme CYP3A4 within 30 days before the first administration (such as inducers-enzalutamide, mitotane, carbamazepine, phenytoin, rifampin; inhibitors-clarithromycin, irradian) Traconazole, ketoconazole, ritonavir, telithromycin, etc.), or those who have used contraceptives within 30 days before administration;
- Those who have used any drug within 14 days before the first dose;
- Those who have taken a special diet (including grapefruit/grapefruit juice, chocolate, food or beverages containing caffeine) within 48 hours before the first administration, or have consumed excessive amounts of tea, coffee or beverages containing caffeine every day for the past 1 month (Average more than 8 cups per day, 200 mL per cup);
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 capsulephase 1 :8mg; phase 2:12mg; phase 3:16mg | Drug | HR19042 capsule |
Primary outcome
Cmax
Time frame: 0-24 hours
Peak concentration of drug observed from 0 hour to 24 hours after administration
AUC0-t;
Time frame: 0-24 hours
The area under the drug concentration-time curve at the sample collection time t that can be accurately determined from 0 hour to 24 hours after administration
AUC0-∞
Time frame: 0 hour to 24 hours
The area under the concentration-time curve of drug from 0 hour to infinity after administration
2 secondary outcomes
AE
Time frame: Screening period to end of follow-up period, approximately 1 month
the change of blood cortisol AUC0-24h from baseline after each cycle of administration
Time frame: 0-24 hours
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 24 Sep 2021.
Related trials for Primary IgA Nephropathy
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Primary IgA Nephropathy
RecruitingPhase 2
A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
Immunoglobulin A Nephropathy (IgAN)
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 in people with Primary IgA Nephropathy, 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 4 inclusion and 21 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 24 Sep 2021. 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 (time frame: 0-24 hours). 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 24 Sep 2021.