Lipoprotein DisorderPhase 1NCT07752069
Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy Participants
A Phase 1 study testing HRS-5346 in people with Lipoprotein Disorder, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a single center, randomized, open label crossover trial planned to include 50 healthy participants to evaluate the relative bioavailability of HRS-5346 new and old formulations in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipoprotein Disorder
- What is being tested?
- HRS-5346
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Voluntary signing of ICF prior to trial initiation; full understanding of trial content, procedures, and potential AEs; willingness to strictly adhere to the protocol and complete the trial.
- Age 18-45 years (inclusive) on ICF signing date; male or female.
- Body weight ≥ 50 kg (male) or ≥ 45 kg (female); BMI between 19 and 28 kg/m² (inclusive).
- No clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal ultrasound, or chest X-ray (or CT), per investigator assessment; QTcF ≤ 450 ms (male) or ≤ 470 ms (female) on 12-lead ECG.
- Willingness to use effective contraception (participants and partners) from ICF signing to 2 weeks post-last dose; negative serum pregnancy test and non-lactating status for female participants.
Who cannot join
- Those with any clinically serious diseases judged by the investigator involving the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or other diseases or medical histories that may interfere with the trial results;
- Those with malignant tumors, or a history of malignant tumors within 5 years before screening (except for non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical intraepithelial neoplasia);
- Those who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before screening, or who are still within 5 half-lives of the above drugs at the time of screening (whichever is longer);
- Those who plan to take medications other than the trial drug during the trial period;
- Those who have participated in any clinical trial of drugs or medical devices within 3 months before screening (participation in a clinical trial is defined as: having given informed consent for a clinical trial and having used the trial drug (including placebo) or trial medical device), and who are still within the follow-up period of a clinical study or within 5 half-lives of the trial drug at the time of screening (whichever is longer);
- Those with a suspected history of allergy to the study drug or any component of the study drug, those with allergic constitution, or those with a history of severe drug allergy;
Show all 20Show fewer
- Those with a previous history of difficulty in blood collection or inability to tolerate venipuncture, such as those with needle phobia or blood phobia;
- Those with a previous history of gastric or intestinal surgery that, in the investigator's opinion, may affect drug absorption, or those with gastrointestinal diseases that may affect drug absorption;
- Those who have had a severe infection, severe trauma, or major surgery within 3 months before screening; or those who plan to undergo surgery during the trial period or within two weeks after its completion;
- Those who have donated blood or experienced blood loss of ≥ 200 mL in total within 1 month before screening, or ≥ 400 mL in total within 3 months before screening, or those who have received a blood transfusion within 8 weeks;
- Those who have smoked an average of ≥ 5 cigarettes per day within 3 months before screening; those who have consumed an average of more than 15 g of alcohol per day within 1 month before screening (5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine, approximately 17 mL of low-alcohol liquor, or 10 mL of high-alcohol liquor), or those who refuse to abstain from smoking, alcohol, and caffeinated foods or beverages during the screening period and the trial period, as well as those with special dietary requirements who cannot adhere to a unified diet;
- Those who, from 48 hours before taking the study drug until the end of the study, refuse to discontinue any beverages containing methylxanthines, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any fruit juices, refuse to refrain from vigorous exercise, or have other factors that may affect drug absorption, distribution, metabolism, or excretion;
- Those with a high-sensitivity C-reactive protein level > 1.5 times the upper limit of normal, or prothrombin time (PT), international normalized ratio (INR), or activated partial thromboplastin time (APTT) > 1.25 times the upper limit of normal during the screening period;
- Those who test positive in the infectious disease screening during the screening period (including hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus antibody, and syphilis antibody);
- Those who have received a vaccination within 1 month before screening or plan to receive a vaccination during the trial or within 1 month after dosing;
- Women who are pregnant or lactating at the screening and baseline visits;
- Those who test positive in the alcohol breath test at the baseline visit;
- Those with a history of drug abuse or substance abuse; or those who test positive in the urine drug test at the screening and baseline visits;
- Staff of the research center or other personnel directly involved in the execution of the protocol;
- Other conditions that, in the investigator's opinion, make the participant unsuitable for participation in this trial, such as physiological or psychological diseases or conditions that may increase the risk of the trial, affect the participant's compliance with the protocol, or affect the participant's ability to complete the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study is a single center, randomized, open label crossover trial planned to include 50 healthy participants to evaluate the relative bioavailability of HRS-5346 new and old formulations in healthy participants. The experimental process includes three stages: screening period, baseline period, and administration observation period.
- Conditions
- Lipoprotein Disorder
- Being tested
- HRS-5346
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5346Drug
Dose A, Dose B
HRS-5346Drug
Dose B, DoseA
| Study group | Role | What they receive |
|---|---|---|
| Queue 1 | Experimental | Not described Receives: Drug: HRS-5346 |
| Queue 2 | Experimental | Not described Receives: Drug: HRS-5346 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: From before administration to one month after administration
AUC0-t
Measured: From before administration to one month after administration
AUC0-inf
Measured: From before administration to one month after administration
Secondary outcomes (5)
Tmax
Measured: From before administration to one month after administration
CL/F
Measured: From before administration to one month after administration
Vz/F
Measured: From before administration to one month after administration
t1/2
Measured: From before administration to one month after administration
Adverse event
Measured: From before administration to one month after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipoprotein DisorderStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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
- NCT07752069
- Sponsor's protocol ID
- HRS-5346-102
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 7 Aug 2026
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07752069
- Acronym / sponsor ID
- HRS-5346-102
- Conditions
- Lipoprotein Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Aug 2026 (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 study is a single center, randomized, open label crossover trial planned to include 50 healthy participants to evaluate the relative bioavailability of HRS-5346 new and old formulations in healthy participants. The experimental process includes three stages: screening period, baseline period, and administration observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Queue 1 | Experimental | Drug: HRS-5346 |
| Queue 2 | Experimental | Drug: HRS-5346 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntary signing of ICF prior to trial initiation; full understanding of trial content, procedures, and potential AEs; willingness to strictly adhere to the protocol and complete the trial.
- Age 18-45 years (inclusive) on ICF signing date; male or female.
- Body weight ≥ 50 kg (male) or ≥ 45 kg (female); BMI between 19 and 28 kg/m² (inclusive).
- No clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal ultrasound, or chest X-ray (or CT), per investigator assessment; QTcF ≤ 450 ms (male) or ≤ 470 ms (female) on 12-lead ECG.
- Willingness to use effective contraception (participants and partners) from ICF signing to 2 weeks post-last dose; negative serum pregnancy test and non-lactating status for female participants.
Key exclusion criteria (20 listed)
- Those with any clinically serious diseases judged by the investigator involving the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or other diseases or medical histories that may interfere with the trial results;
- Those with malignant tumors, or a history of malignant tumors within 5 years before screening (except for non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical intraepithelial neoplasia);
- Those who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before screening, or who are still within 5 half-lives of the above drugs at the time of screening (whichever is longer);
- Those who plan to take medications other than the trial drug during the trial period;
- Those who have participated in any clinical trial of drugs or medical devices within 3 months before screening (participation in a clinical trial is defined as: having given informed consent for a clinical trial and having used the trial drug (including placebo) or trial medical device), and who are still within the follow-up period of a clinical study or within 5 half-lives of the trial drug at the time of screening (whichever is longer);
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-5346Dose A, Dose B | Drug | Queue 1 |
| HRS-5346Dose B, DoseA | Drug | Queue 2 |
Primary outcome
Cmax
Time frame: From before administration to one month after administration
AUC0-t
Time frame: From before administration to one month after administration
AUC0-inf
Time frame: From before administration to one month after administration
5 secondary outcomes
Tmax
Time frame: From before administration to one month after administration
CL/F
Time frame: From before administration to one month after administration
Vz/F
Time frame: From before administration to one month after administration
t1/2
Time frame: From before administration to one month after administration
Adverse event
Time frame: From before administration to one month after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Lipoprotein Disorder
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingPhase 2
Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
Lipoprotein Disorder
Active, not recruitingPhase 3
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
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.
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 in people with Lipoprotein Disorder, 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 20 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: opening soon, as of the sponsor's last update on 7 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weijie Kong (0518-82342973, weijie.kong.wk1@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: From before administration to one month after administration). 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 7 Aug 2026.