HypertensionPhase 1NCT03645278
The PK/PD Study of SHR0532 Tablets in Healthy Subjects
A Phase 1 study testing SHR0532 in people with Hypertension, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
In the last four decades, several classes of diuretics have been the first line option for the therapy of widespread hypertension. However, all the classes of diuretics cause alteration of potassium homeostasis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- SHR0532
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2018to 30 Apr 2019
- 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
- males or females, aged 18-45
- subjects have no cardiovascular disease, with sitting blood pressure: 90mmHg ≤SBP<140mmHg and 60mmHg ≤DBP<90mmHg;
- body mass index (BMI) between 19 to 26, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg
- Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on electrocardiogram, X-ray, Echocardiograph and B-type ultrasonic
Who cannot join
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1.5 x ULN during screening/baseline;
- Serum creatinine>ULN)during screening/baseline;
- Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) test positive;
- Known postural hypotension; the numeric difference of systolic blood pressure between both upper limbs >20mmHg；
- A clinical history of arrhythmia；subjects with Electrocardiogram QTc prolongation（male>450ms；female>460ms）during screening；
- A clinical history of hyperuricemia；serum uric acid > the upper limit of normal value (ULN) during screening;
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- A clinical history of diabetes；fasting plasma glucose or hemoglobin A1c exceeded the upper limit of normal value (ULN) during screening;
- Subjects with previous GI discomfort -abdominal pain, diarrhea, and nausea 3 months prior to screening；
- A clinical history of acute or chronic kidney disease;
- Subjects with severe trauma or surgery within 3 months prior to the screening； 11.3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening;
- 12.Pregnant or Serum β-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR0532 Tablets in Healthy Subjects
In the last four decades, several classes of diuretics have been the first line option for the therapy of widespread hypertension. However, all the classes of diuretics cause alteration of potassium homeostasis. The primary objective of this study is to assess the safety and tolerability of SHR0532 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR0532 tablets in healthy subjects.
- Conditions
- Hypertension
- Being tested
- SHR0532, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0532Drug
Ascending dose oral adminstration
PlaceboDrug
Ascending dose oral administration
| Study group | Role | What they receive |
|---|---|---|
| SHR0532 | Experimental | Up to 5 cohorts of healthy subjects will receive a single dose of oral SHR0532 tablet. Receives: Drug: SHR0532 |
| Placebo | Experimental | Up to 5 cohorts of healthy subjects will receive a single dose of oral placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and serious adverse events
Measured: Pre-dose to 5 days after dose administration
Secondary outcomes (8)
Area under the plasma concentration versus time curve (AUC) of SHR-0532
Measured: Pre-dose to 5 days after dose administration
Maximum observed serum concentration (Cmax) of SHR-0532
Measured: Pre-dose to 5 days after dose administration
Time to maximum observed serum concentration (tmax) of SHR-0532
Measured: Pre-dose to 5 days after dose administration
Time to elimination half-life (t1/2) of SHR-0532
Measured: Pre-dose to 5 days after dose administration
Apparent total clearance of the drug from plasma after oral administration (CL/F) of SHR-0532
Measured: Pre-dose to 5 days after dose administration
Apparent volume of distribution after non-intravenous administration (V/F) of SHR-0532
Measured: Pre-dose to 5 days after dose administration
Renal clearance of the drug from plasma (CLR) of SHR-0532
Measured: Pre-dose to 5 days after dose administration
Cumulative amount of unchanged drug excreted into the urine(Ae) of SHR-0532
Measured: Pre-dose to 5 days after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start24 Aug 2018 (estimated)
- Primary completion15 Dec 2018 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
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
- NCT03645278
- Sponsor's protocol ID
- SHR0532-101
- Status last verified
- Aug 2018
- First submitted
- 12 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR0532 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03645278
- Acronym / sponsor ID
- SHR0532-101
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2018 (estimated)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 24 Aug 2018 (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.
In the last four decades, several classes of diuretics have been the first line option for the therapy of widespread hypertension. However, all the classes of diuretics cause alteration of potassium homeostasis. The primary objective of this study is to assess the safety and tolerability of SHR0532 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR0532 tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR0532 | Experimental | Drug: SHR0532Up to 5 cohorts of healthy subjects will receive a single dose of oral SHR0532 tablet. |
| Placebo | Experimental | Drug: PlaceboUp to 5 cohorts of healthy subjects will receive a single dose of oral placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- males or females, aged 18-45
- subjects have no cardiovascular disease, with sitting blood pressure: 90mmHg ≤SBP<140mmHg and 60mmHg ≤DBP<90mmHg;
- body mass index (BMI) between 19 to 26, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg
- Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on electrocardiogram, X-ray, Echocardiograph and B-type ultrasonic
Key exclusion criteria (11 listed)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1.5 x ULN during screening/baseline;
- Serum creatinine>ULN)during screening/baseline;
- Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) test positive;
- Known postural hypotension; the numeric difference of systolic blood pressure between both upper limbs >20mmHg；
- A clinical history of arrhythmia；subjects with Electrocardiogram QTc prolongation（male>450ms；female>460ms）during 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 |
|---|---|---|
| SHR0532Ascending dose oral adminstration | Drug | SHR0532 |
| PlaceboAscending dose oral administration | Drug | Placebo |
Primary outcome
Number of subjects with adverse events and serious adverse events
Time frame: Pre-dose to 5 days after dose administration
8 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of SHR-0532
Time frame: Pre-dose to 5 days after dose administration
Maximum observed serum concentration (Cmax) of SHR-0532
Time frame: Pre-dose to 5 days after dose administration
Time to maximum observed serum concentration (tmax) of SHR-0532
Time frame: Pre-dose to 5 days after dose administration
Time to elimination half-life (t1/2) of SHR-0532
Time frame: Pre-dose to 5 days after dose administration
Apparent total clearance of the drug from plasma after oral administration (CL/F) of SHR-0532
Time frame: Pre-dose to 5 days after dose administration
Apparent volume of distribution after non-intravenous administration (V/F) of SHR-0532
Time frame: Pre-dose to 5 days after dose administration
Renal clearance of the drug from plasma (CLR) of SHR-0532
Time frame: Pre-dose to 5 days after dose administration
Cumulative amount of unchanged drug excreted into the urine(Ae) of SHR-0532
Time frame: Pre-dose to 5 days after dose administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR0532 in people with Hypertension, run by Jiangsu HengRui Medicine Co., Ltd..
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 11 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yuanwei Jia, Ph.D. (+86-15155324471, jiayuanwei123925@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events and serious adverse events (time frame: Pre-dose to 5 days after dose administration). 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 Aug 2018.