Lipoprotein Disorder DiseasePhase 1NCT06441227
Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects
A Phase 1 study testing HRS-5346 tablets in people with Lipoprotein Disorder 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-5346 in healthy subjects, and to evaluate the food effects on PK of HRS-5346. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipoprotein Disorder Disease
- What is being tested?
- HRS-5346 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2024to 9 Jan 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the specific process of the test, voluntarily participate in this test, and sign the informed consent in writing.
- Age ≥ 18 and ≤ 55 years old on the day of signing the informed consent (including boundary value).
- Male subjects weigh ≥ 50 kg, female subjects weigh ≥ 45kg, and BMI is in the range of 19~30 kg/m2 (including boundary values).
- Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from the time of signing the informed consent form to the last time the drug is given; the female subject's blood pregnancy test must be negative and non-lactation.
- Normal or abnormality such as vital signs, physical examination and laboratory examination have no clinical significance.
Who cannot join
- Those who suffer from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease or medical history that can interfere with the test results or any significant laboratory abnormality that is judged by researchers to be of clinical significance.
- Previous history of malignant tumors.
- Those who have taken any prescription drugs, over-the-counter drugs and Chinese herbs within 14 days before taking the study drug, or within 5 half-life of the drug at the time of screening; those who plan to take non-study drugs during the trial period.
- Those who have participated in the clinical trial of any drug or medical device within 3 months before screening, or have not been within 5 half-life of the drug before screening (when both standards are met, the standard shall be based on the long-term standard).
- Subjects received siRNA in the past 12 months, or antisense oligonucleotide drugs in the past six months.
- The abnormal upper limit of hypersensitive C-reactive protein during the screening period is >1.5 times the normal upper limit, or the normal upper limit of prothrombin time/international standard ratio (PT/INR), activated partial thrombin time (aPTT) > 1.25 times normal upper limit.
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- Screening for infectious diseases during the screening period (including hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis spirochete antibody).
- 12-lead electrocardiogram abnormal and clinical significance, or electrocardiogram QT interval (QTcF) male > 450 ms, female > 470 ms.
- The total amount of blood donated or blood loss ≥ 200 mL within 1 month before administration, or the total amount of blood donation or blood loss ≥ 400 mL within 3 months before administration, or received blood transfusion within 8 weeks.
- Those who have a serious infection, serious trauma or major surgery within 3 months before administration; those who plan to undergo surgery within two weeks during and after the end of the trial.
- Suspected people with a history of allergy to research drugs or any ingredients in research drugs, allergies or previous history of serious drug allergies.
- People who have had blood collection difficulties or cannot tolerate venous punctures in the past, such as needle fainting and blood fainting.
- Glomerular filtration rate (eGFR) is lower than GFR 60 mL/min/1.73 m2.
- Smoke an average of ≥ 5 cigarettes per day in the first three months of administration; the average daily intake of alcohol in the first month before administration exceeded 15 grams.
- Screening and visiting drug screening test is positive or alcohol breath test is positive.
- Other circumstances in which the researcher believes that the subject is not suitable to participate in this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215008
About this study
Official title: Phase I Clinical Study on the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Food Effects of Single and Multiple Oral HRS-5346 Tablets in Healthy 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-5346 in healthy subjects, and to evaluate the food effects on PK of HRS-5346.
- Conditions
- Lipoprotein Disorder Disease
- Being tested
- HRS-5346 tablets, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5346 tabletsDrug
Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses.
placeboDrug
Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | HRS-5346 tablets or placebo single dose Receives: Drug: HRS-5346 tablets; Drug: placebo |
| Part 2 | Experimental | HRS-5346 tablets or placebo single dose with food effects Receives: Drug: HRS-5346 tablets; Drug: placebo |
| Part 3 | Experimental | HRS-5346 tablets or placebo multiple doses Receives: Drug: HRS-5346 tablets; Drug: 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-5346 tablets
Measured: About three months from the first medication to the evaluation
Secondary outcomes (10)
Evaluation of AUC0-t of HRS-5346 in plasma and urine
Measured: About three months after the first dose
Evaluation of AUC0-inf of HRS-5346 in plasma
Measured: About three months after the first dose
Evaluation of Tmax of HRS-5346 in plasma
Measured: About three months after the first dose
Evaluation of Cmax of HRS-5346 in plasma
Measured: About three months after the first dose
Evaluation of t1/2 of HRS-5346 in plasma
Measured: About three months after the first dose
Evaluation of CL/F of HRS-5346 in plasma
Measured: About three months after the first dose
Evaluation of Vz/F of HRS-5346 in plasma
Measured: About three months after the first dose
Evaluation of Ae of HRS-5346 in urine
Measured: About three months after the first dose
Evaluation of fe of HRS-5346 in urine
Measured: About three months after the first dose
Evaluation of CLR of HRS-5346 in urine
Measured: About three months 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 posted4 Jun 2024
- Study start13 Jun 2024
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipoprotein Disorder 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
- 71 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
- NCT06441227
- Sponsor's protocol ID
- HRS-5346-101
- Status last verified
- Apr 2025
- First submitted
- 28 May 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Food Effects of Single and Multiple Oral HRS-5346 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06441227
- Acronym / sponsor ID
- HRS-5346-101
- Conditions
- Lipoprotein Disorder Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 4 Jun 2024 (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-5346 in healthy subjects, and to evaluate the food effects on PK of HRS-5346.
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-5346 tablets, Drug: placeboHRS-5346 tablets or placebo single dose |
| Part 2 | Experimental | Drug: HRS-5346 tablets, Drug: placeboHRS-5346 tablets or placebo single dose with food effects |
| Part 3 | Experimental | Drug: HRS-5346 tablets, Drug: placeboHRS-5346 tablets or placebo multiple doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Understand the specific process of the test, voluntarily participate in this test, and sign the informed consent in writing.
- Age ≥ 18 and ≤ 55 years old on the day of signing the informed consent (including boundary value).
- Male subjects weigh ≥ 50 kg, female subjects weigh ≥ 45kg, and BMI is in the range of 19~30 kg/m2 (including boundary values).
- Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from the time of signing the informed consent form to the last time the drug is given; the female subject's blood pregnancy test must be negative and non-lactation.
- Normal or abnormality such as vital signs, physical examination and laboratory examination have no clinical significance.
Key exclusion criteria (16 listed)
- Those who suffer from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease or medical history that can interfere with the test results or any significant laboratory abnormality that is judged by researchers to be of clinical significance.
- Previous history of malignant tumors.
- Those who have taken any prescription drugs, over-the-counter drugs and Chinese herbs within 14 days before taking the study drug, or within 5 half-life of the drug at the time of screening; those who plan to take non-study drugs during the trial period.
- Those who have participated in the clinical trial of any drug or medical device within 3 months before screening, or have not been within 5 half-life of the drug before screening (when both standards are met, the standard shall be based on the long-term standard).
- Subjects received siRNA in the past 12 months, or antisense oligonucleotide drugs in the past six months.
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-5346 tabletsPart 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses. | Drug | Part 1, Part 2, Part 3 |
| placeboPart 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses. | Drug | Part 1, Part 2, Part 3 |
Primary outcome
Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-5346 tablets
Time frame: About three months from the first medication to the evaluation
10 secondary outcomes
Evaluation of AUC0-t of HRS-5346 in plasma and urine
Time frame: About three months after the first dose
Evaluation of AUC0-inf of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of Tmax of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of Cmax of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of t1/2 of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of CL/F of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of Vz/F of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of Ae of HRS-5346 in urine
Time frame: About three months after the first dose
Evaluation of fe of HRS-5346 in urine
Time frame: About three months after the first dose
Evaluation of CLR of HRS-5346 in urine
Time frame: About three months after the first dose
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 29 Apr 2025.
- 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 testing HRS-5346 tablets in people with Lipoprotein Disorder 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 5 inclusion and 16 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 29 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?
Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-5346 tablets (time frame: About three months 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?
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 29 Apr 2025.