DyslipidemiaPhase 1NCT06732154
A Phase I Clinical Study of a Single Subcutaneous Injection of HRS-5632 in Healthy Subjects
A Phase 1 study testing HRS-5632 in people with Dyslipidemia, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HRS-5632 Following a Single Subcutaneous Injection in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- HRS-5632
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2024to 2 Mar 2026
- 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 procedures of the trial, voluntarily participate in this trial, and sign an informed consent form;
- Age on the day of signing the informed consent form must be ≥18 and ≤55 years old (inclusive of boundary values);
- Male subjects must weigh ≥50 kg and female subjects must weigh ≥45 kg, with a Body Mass Index (BMI) within the range of 19 to 30 kg/m² (inclusive of boundary values);
- Female subjects with childbearing potential must agree to use effective contraception and avoid donating eggs from the time of signing the informed consent form until the end of the trial. Serum pregnancy tests within 7 days before the first dosing and during the trial must be negative, and they must not be breastfeeding; Male subjects with partners who have childbearing potential must agree to use effective contraception and avoid donating sperm from the time of signing the informed consent form until 6 months after the last administration of the trial medication;
- Vital signs, physical examinations, and laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function, thyroid function, sex hormones), 12-lead electrocardiogram, chest X-ray, and abdominal ultrasound must be normal or have abnormalities without clinical significance.
Who cannot join
- Subjects with any clinically significant diseases or medical history in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic systems, or any other diseases or histories that could interfere with the trial results or any significant laboratory abnormalities judged by the investigator to be clinically meaningful;
- History of malignant tumors;
- Use of any prescription, over-the-counter, or traditional Chinese medicine within 14 days prior to the study drug administration, or within 7 half-lives of the drug at the time of screening;
- Participation in any clinical trial of drugs or medical devices within the last 3 months, or still within 7 half-lives of the drug at the time of screening (the longer standard shall prevail if both are met);
- Subjects who plan to take lipid-lowering or lipid-affecting drugs not part of this study during the trial;
- Elevated high-sensitivity C-reactive protein >1.5 times the upper limit of normal, or prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (APTT) >1.25 times the upper limit of normal during the screening period;
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- Positive results in infectious disease screening (including hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis spirochete antibody);
- Abnormal 12-lead electrocardiogram with clinical significance, or electrocardiogram QT interval (QTcF) > 450 ms in males, > 470 ms in females;
- Blood donation or blood loss of ≥ 200 mL within the last month before dosing, or ≥ 400 mL within the last 3 months before dosing, or receipt of blood transfusion within the last 8 weeks;
- History of severe infection, severe trauma, or major surgery within the last 3 months before dosing; planning to undergo surgery during the trial and within two weeks after trial completion;
- Suspected history of allergy to the study drug or any component of the study drug, allergic constitution, or history of severe drug allergies;
- History of difficulty with blood draws or intolerance to venipuncture, such as fainting at the sight of needles or blood;
- Glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² (estimated using the CKD-EPI equation);
- Average daily smoking of ≥ 5 cigarettes in the three months before dosing; average daily alcohol intake exceeding 15 g in the month before dosing (5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine, about 17 mL of low-proof spirits, or 10 mL of high-proof spirits);
- Positive drug screen at the screening visit or positive alcohol breath test;
- For subjects participating in QT/QTc studies: (1) Heart rate > 100 bpm, congenital QT interval prolongation syndrome, or family history of congenital QT interval prolongation, with implanted pacemakers, automatic implantable cardioverter-defibrillators; (2) Use of antiarrhythmic drugs, cardiac drugs, beta-blockers, calcium channel blockers, quinolones, and other drugs that prolong QT/QTc interval or cause risk of torsades de pointes (TdP) within 4 weeks before the first use of the trial drug;
- Any other conditions deemed by the investigator to make the subject unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of HRS-5632 in Healthy Subjects
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HRS-5632 Following a Single Subcutaneous Injection in Healthy Subjects
- Conditions
- Dyslipidemia
- Being tested
- HRS-5632, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5632Drug
HRS-5632 Injection
PlaceboDrug
Sodium chloride injection
| Study group | Role | What they receive |
|---|---|---|
| HRS-5632 | Experimental | Not described Receives: Drug: HRS-5632 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of all reported adverse events, serious adverse events and treatment-related adverse events, serious adverse events.
Measured: from the single dose administration (Day 1) to Day 337
Secondary outcomes (2)
Area under the concentration time curve (AUC) of HRS-5632
Measured: Following a single subcutaneous injection（Day1）to Day4,
Maximum observed drug concentration (Cmax) of HRS-5632
Measured: Following a single subcutaneous injection（Day1）to Day4,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start2 Dec 2024
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical 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 (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732154
- Sponsor's protocol ID
- HRS-5632-101
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2024
- Last updated
- 3 Apr 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of HRS-5632 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06732154
- Acronym / sponsor ID
- HRS-5632-101
- Conditions
- Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 13 Dec 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.
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HRS-5632 Following a Single Subcutaneous Injection 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 |
|---|---|---|
| HRS-5632 | Experimental | Drug: HRS-5632 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Understand the specific procedures of the trial, voluntarily participate in this trial, and sign an informed consent form;
- Age on the day of signing the informed consent form must be ≥18 and ≤55 years old (inclusive of boundary values);
- Male subjects must weigh ≥50 kg and female subjects must weigh ≥45 kg, with a Body Mass Index (BMI) within the range of 19 to 30 kg/m² (inclusive of boundary values);
- Female subjects with childbearing potential must agree to use effective contraception and avoid donating eggs from the time of signing the informed consent form until the end of the trial. Serum pregnancy tests within 7 days before the first dosing and during the trial must be negative, and they must not be breastfeeding; Male subjects with partners who have childbearing potential must agree to use effective contraception and avoid donating sperm from the time of signing the informed consent form until 6 months after the last administration of the trial medication;
- Vital signs, physical examinations, and laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function, thyroid function, sex hormones), 12-lead electrocardiogram, chest X-ray, and abdominal ultrasound must be normal or have abnormalities without clinical significance.
Key exclusion criteria (17 listed)
- Subjects with any clinically significant diseases or medical history in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic systems, or any other diseases or histories that could interfere with the trial results or any significant laboratory abnormalities judged by the investigator to be clinically meaningful;
- History of malignant tumors;
- Use of any prescription, over-the-counter, or traditional Chinese medicine within 14 days prior to the study drug administration, or within 7 half-lives of the drug at the time of screening;
- Participation in any clinical trial of drugs or medical devices within the last 3 months, or still within 7 half-lives of the drug at the time of screening (the longer standard shall prevail if both are met);
- Subjects who plan to take lipid-lowering or lipid-affecting drugs not part of this study during the trial;
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-5632HRS-5632 Injection | Drug | HRS-5632 |
| PlaceboSodium chloride injection | Drug | Placebo |
Primary outcome
The percentage of all reported adverse events, serious adverse events and treatment-related adverse events, serious adverse events.
Time frame: from the single dose administration (Day 1) to Day 337
2 secondary outcomes
Area under the concentration time curve (AUC) of HRS-5632
Time frame: Following a single subcutaneous injection（Day1）to Day4,
Maximum observed drug concentration (Cmax) of HRS-5632
Time frame: Following a single subcutaneous injection（Day1）to Day4,
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 3 Apr 2026.
- 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-5632 in people with Dyslipidemia, run by Fujian Shengdi Pharmaceutical 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 17 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 3 Apr 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. Some participants in this study may receive a placebo. 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?
The percentage of all reported adverse events, serious adverse events and treatment-related adverse events, serious adverse events. (time frame: from the single dose administration (Day 1) to Day 337). 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 3 Apr 2026.