Chronic Kidney DiseasePhase 1NCT05638126
Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects
A Phase 1 study of Chronic Kidney Disease, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780. 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
- Chronic Kidney Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2023to Dec 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
- 18-45 years old (including boundary value, whichever is at the time of signing the informed consent form), healthy male.
- Weight ≥50 kg, body mass index (BMI = body mass/height square (kg/m2)) is in the range of 18-28 (including boundary values)
- Obtain informed consent before any activity related to the experiment begins, have a full understanding of the purpose and significance of the experiment, and be willing to comply with the test plan and dietary requirements.
- Subjects (including partners) have no family planning within 3 months from the beginning of the signing of the informed consent form to the last dose, and are willing to adopt the efficient contraceptive measures stipulated in the program and guarantee not to donate sperm.
Who cannot join
- People with a history of hypertension.
- People with severe systemic infectious diseases, serious trauma or major surgical surgery before screening; those who plan to undergo surgery during the trial
- There has been a history of clinical abnormal gastric emptying and severe chronic gastrointestinal diseases.
- Diseases found to show clinical significance before screening
- Combined with diuretics before screening
- Drugs were used 2 weeks before screening.
Show all 18Show fewer
- Laboratory or physical examination with any abnormalities and the researcher's judgment is clinically significant.
- 12-lead electrocardiogram is abnormal and of clinical significance
- Positive for hepatitis B surface antigen, positive for hepatitis C antibody, positive for syphilis spirochete antibody, positive for HIV antibody
- People with severe allergic diseases or known or suspected of being allergic to any of the ingredients in the research drug, allergic constitution (multiple drugs and food allergies)
- Participated in the clinical trial of any drug or medical device within the first 3 months of screening or planned to participate in the clinical trial of other drugs or medical devices during the trial period (subject to the signing of informed consent)
- Drink more than 14 units of alcohol per week in the first 6 months of screening; or those who have taken alcohol products 48 hours before administration; or those who have tested positive for alcohol exhalation during the baseline period.
- Smoking more than 5 cigarettes a day in the 3 months before screening or using any tobacco products 48 h before administration.
- Drink/eat coffee, tea, grapefruit, chocolate or soft drinks, such as cola containing methamphetrine (tein, caffeine or cocoaine) within 3 days before screening
- Those who have had a history of drug abuse in the past five years or have used drugs in the first three months of the trial; or urine drugs are screened positive
- Blood donation ≥ 200 mL within 1 month before screening; or blood donation ≥ 400 mL within 3 months before screening; or trauma or surgical surgery with blood donation (plasma or platelets) or blood loss of ≥ 400 mL within 2 weeks
- Inability tolerate venous puncture and blood collection or dizziness
- Subjects who believe that there are other factors that are not suitable to participate in this test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Single and Multiple Ascending Dose and Food Effect Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-1780 Tablets in Healthy Male Subjects
This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.
- Conditions
- Chronic Kidney Disease
- Being tested
- HRS-1780 table or placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1780 table or placeboDrug
HRS-1780 table or placebo single dose
HRS-1780 table or placeboDrug
HRS-1780 table or placebo single dose with food effect
HRS-1780 table or placeboDrug
HRS-1780 table or placebo multiple dose
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | HRS-1780 table or placebo single dose Receives: Drug: HRS-1780 table or placebo |
| Part 2 | Experimental | HRS-1780 table or placebo single dose with food effect Receives: Drug: HRS-1780 table or placebo |
| Part 3 | Experimental | HRS-1780 table or placebo multiple dose Receives: Drug: HRS-1780 table or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-1780 tablets
Measured: About a month from the first medication to the evaluation.
Secondary outcomes (13)
Assess the concentration of HRS-1780 in plasma and urine
Measured: About 4 weeks after the first dose
Evaluation of AUC0-t of HRS-1780 in plasma and urine
Measured: About 4 weeks after the first dose
Evaluation of AUC0-∞ of HRS-1780 in plasma and urine
Measured: About 4 weeks after the first dose
Evaluation of Tmax of HRS-1780 in plasma and urine
Measured: About 4 weeks after the first dose
Evaluation of Cmax of HRS-1780 in plasma and urine
Measured: About 4 weeks after the first dose
Evaluation of t1/2 of HRS-1780 in plasma and urine
Measured: About 4 weeks after the first dose
Evaluate the blood pressure of subjects over time after HRS-1780 administration
Measured: About 4 weeks after the first dose
Evaluate the heart rate of subjects over time after HRS-1780 administration
Measured: About 4 weeks after the first dose
Evaluate the concentrations of plasma renin activity of subjects over time after HRS-1780 administration
Measured: About 4 weeks after the first dose
Evaluate the plasma aldosterone of subjects over time after HRS-1780 administration
Measured: About 4 weeks after the first dose
Evaluate the plasma angiotensin II of subjects over time after HRS-1780 administration
Measured: About 4 weeks after the first dose
Evaluate the urinary creatinine curve of subjects with time after HRS-1780 administration
Measured: About 4 weeks after the first dose
Evaluate the change curve of urine creatinine over time relative to baseline in subjects after HRS-1780 administration
Measured: About 4 weeks after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start2 Feb 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638126
- Sponsor's protocol ID
- HRS-1780-101
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shen Q, Li L, Qian W, Dong X, Bao M, Huang R, Li N, Ye Z, Cheng G, Wang Q, Shen K, Luo Z. A four-in-one first-in-human study to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and concentration-QTc relationship of HRS-1780, a selective non-steroidal mineralocorticoid receptor antagonist, in healthy men. Expert Opin Investig Drugs. 2024 Oct;33(10):1083-1093. doi: 10.1080/13543784.2024.2393867. Epub 2024 Aug 26.
PubMed 39155700
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single and Multiple Ascending Dose and Food Effect Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-1780 Tablets in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05638126
- Acronym / sponsor ID
- HRS-1780-101
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Dec 2022 (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 randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: HRS-1780 table or placeboHRS-1780 table or placebo single dose |
| Part 2 | Experimental | Drug: HRS-1780 table or placeboHRS-1780 table or placebo single dose with food effect |
| Part 3 | Experimental | Drug: HRS-1780 table or placeboHRS-1780 table or placebo multiple dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-45 years old (including boundary value, whichever is at the time of signing the informed consent form), healthy male.
- Weight ≥50 kg, body mass index (BMI = body mass/height square (kg/m2)) is in the range of 18-28 (including boundary values)
- Obtain informed consent before any activity related to the experiment begins, have a full understanding of the purpose and significance of the experiment, and be willing to comply with the test plan and dietary requirements.
- Subjects (including partners) have no family planning within 3 months from the beginning of the signing of the informed consent form to the last dose, and are willing to adopt the efficient contraceptive measures stipulated in the program and guarantee not to donate sperm.
Key exclusion criteria (18 listed)
- People with a history of hypertension.
- People with severe systemic infectious diseases, serious trauma or major surgical surgery before screening; those who plan to undergo surgery during the trial
- There has been a history of clinical abnormal gastric emptying and severe chronic gastrointestinal diseases.
- Diseases found to show clinical significance before screening
- Combined with diuretics before screening
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 |
|---|---|---|
| HRS-1780 table or placeboHRS-1780 table or placebo single dose | Drug | Part 1 |
| HRS-1780 table or placeboHRS-1780 table or placebo single dose with food effect | Drug | Part 2 |
| HRS-1780 table or placeboHRS-1780 table or placebo multiple dose | Drug | Part 3 |
Primary outcome
Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-1780 tablets
Time frame: About a month from the first medication to the evaluation.
13 secondary outcomes
Assess the concentration of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of AUC0-t of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of AUC0-∞ of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of Tmax of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of Cmax of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluation of t1/2 of HRS-1780 in plasma and urine
Time frame: About 4 weeks after the first dose
Evaluate the blood pressure of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the heart rate of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the concentrations of plasma renin activity of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the plasma aldosterone of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the plasma angiotensin II of subjects over time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the urinary creatinine curve of subjects with time after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Evaluate the change curve of urine creatinine over time relative to baseline in subjects after HRS-1780 administration
Time frame: About 4 weeks after the first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Derived from this study: PubMed 39155700Shen Q, Li L, Qian W, Dong X, Bao M, Huang R, Li N, Ye Z, Cheng G, Wang Q, Shen K, Luo Z. A four-in-one first-in-human study to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and concentration-QTc relationship of HRS-1780, a selective non-steroidal mineralocorticoid receptor antagonist, in healthy men. Expert Opin Investig Drugs. 2024 Oct;33(10):1083-1093. doi: 10.1080/13543784.2024.2393867. Epub 2024 Aug 26.
- 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. 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 of Chronic Kidney Disease, run by Shandong Suncadia 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 18 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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. 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?
Results are not available in the source record.
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?
Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-1780 tablets (time frame: About a month from the first medication to the evaluation.). 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 NCT05638126, 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 25 Oct 2023.